State Consumer Disputes Redressal Commission
Smt. Damyanti Devi vs Opal Hospital on 24 February, 2023
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. CC/38/2016 ( Date of Filing : 10 Feb 2016 ) 1. Smt. Damyanti Devi Varanasi ...........Complainant(s) Versus 1. Opal Hospital Varanasi ............Opp.Party(s) BEFORE: HON'BLE MR. Rajendra Singh PRESIDING MEMBER HON'BLE MR. Vikas Saxena JUDICIAL MEMBER PRESENT: Dated : 24 Feb 2023 Final Order / Judgement Reserved State Consumer Disputes Redressal Commission U.P. Lucknow. Complaint Case No. 38 of 2016 SmtDamyanti Singh, aged about 56 years W/O Shri Jagdishwar Singh R/o House number 18, VarunaVihar Colony Sikraul , Varanasi ...Complainant. Versus Opal Hospital, A Multispecialty Hospital, Pvt Ltd Co ,having its office atN 10/60-2 Kakarmatta , DLW Road , Varanasi through its Director Dr Pramod Kumar Rai, Adult,MBBS,MS FRCS(I)Ph.D (Laser Surgery) S/o not Known to the applicant, N 10/60-2, Kakarmatta , DLW Road , Varanasi Dr Smt Sunita Rai ,adult W/o not known to the applicant, Kakarmatta , DLW Road , ...Opposite parties. Present:- 1- Hon'ble Sri Rajendra Singh, Member. 2- Hon'ble Sri Vikas Saxena, Member. Sri Ajay Wahi Advocate for the complainant Sri Vishnu Kumar Mishra , Advocate for OPs. JUDGMENT :
09.03.2023 Per Sri Rajendra Singh, Presiding Member-In brief the facts of the complaint case are that, that the complainant is a housewife and had been keeping good health all through her life except minor hypothyroidism a few years back. The complainant felt pain in abdomen and back in the first week of February 2014 and consulted family doctor Dr DN Singh. On the reference of Dr DN Singh she got ultrasound done of her abdomen and pelvis at Sirona Diagnostic on 12.02.2014. The ultrasound report revealed the following impression-
"cholecystitis with echogenic gallbladder sludge. Small left renal Concretion ."
The complainant showed this ultrasound report to her family doctor and on his suggestion she consulted Dr Pramod Kumar Rai , opposite party -2 at opposite party-1 on 13.02.2014. The opposite party - 2 examined the complainant on 13.02.2014 together with ultrasound report and past medical treatment. The opposite party - 2 advised certain tests and medication. All the tests reports were received on 14.02.2014. On 15.02.2014 , opposite party - 2 Dr Pramod Kumar Rai got the complainant admitted in early hours to opposite party - 1, Opal Hospital and planned to conduct chole by laparoscopic method. The complainant was taken to operation theatre at about 9 AM along with Dr Pramod Kumar Rai, opposite party - 2 and Dr Sunita Rai ,opposite party - 3 and other staffs of the opposite party - 2. Dr Pramod Kumar Rai instructed Dr Sunita Rai to give anaesthesia to the complainant and went away. Dr Sunita Rai instructed the complainant to be in supine position and thereafter inserted a needle in the spine of the complainant. The complainant felt current like shock sensation in her right leg. The opposite party - 3 immediately took out the needle and inserted the needle again in the spine of the complainant. The complainant again failed current like shock sensation in her right leg then the opposite party - 3 instructed the medical staff present in the operation theatre to hold the complainant from both sides by twostaff and one staff to hold the head of the complainant. Thereafter opposite party - 3 inserted the needle for the third time in the spine of the complainant and again the complainant felt same current like shock in her right leg but the anaesthetic medicine was injected this time by Dr Sunita Rai , opposite party - 3.
After the complainant regained consciousness she tried to move her right leg but was unable to do so. However other body parts were working normally. At about 3 PM Dr Pramod Kumar Rai , opposite party - 2 came for checkup. He was informed by the complainant and her husband that there is no movement in the right leg of the complainant. Dr Pramod Kumar Rai took it very causally and stated that it is only because of effect of anaesthetic drug which will subside in next 48 hours. Dr Sunita Rai did not visit the complainant after giving anaesthesia to examine the post-operative effect of anaesthesia. On 16.02.2014 , lack of sensation continued in the right leg of complainant. This fact was informed to the Dr Pramod Kumar Rai and other attending doctors but no attention was paid either by Dr Pramod Kumar Rai or by any other attending doctors. On 17.02.2014 lac of sensation continued in the right leg of the complainant. The complainant and her husband were worried as even after 48 hours of regaining consciousness there was no sensation and movement in right leg of the complainant. The complain was made to Dr Pramod Kumar Rai but he did not call for any neuro or anaesthesia specialist to examine the complainant. After 17.02.2014 when catheter was removed, the complainant tried to get of the bed and move herself but while getting down she fell down as her right leg had no power and sensation. In fact her right leg had become virtually paralysed. This fact was informed to opposite party - 2, then he very reluctantly called Dr Kaushal Agrawal , and orthopaedic surgeon in the night but no advice of new surgeon or anesthetist was taken in spite of the complainants request.
On 18.02.2014 the husband of the complainant, at about 11 AM, called for the entire case record of the complainant and after perusal found that there was no report of anaesthetist in the records. Dr Pramod Kumar Rai, opposite party - 2 stated that anaesthetist has not given her reports so for and she will be asked to submit her report. The anaesthetist report was not attached in the treatment record on 19.02.2014. On 20.02.2014 when the husband of the complainant again examine the treatment record and found that the anaesthetist report being attached on a separate sheet signed and dated back on 15.02.2014 . The husband of the complainant immediately met Dr Sunita Rai , opposite party - 3 and asked her why she has submitted the report in back date, why was there interpolation in the size of needle and why was she written two pricks of needle whereas complainant had informed that three pricks were given to her. She replied that in normal course the anaesthesia report, if required, only then it is prepared and that too in the date i.e, back date of giving the anaesthesia but no reply was given regarding interpolation made by her in report about the size of needle and she admitted that in fact three pricks of needle were given in the spine of the complainant and in the third attempt anaesthetic drug was injected to the complainant. The husband of the complainant on 18.02.2014 , on his personal level, requested Dr Rakesh Singh, neurosurgeon and professor Dr DK Singh anaesthetist to visit and examine the patient as Dr Pramod Kumar Rai did not call them. Dr Rakesh Singh after examining the complainant made the following observations -
patient not able to walk on 17th unable to put right foot properly on ground.
O/E not able to Dorsiflex Right Foot .
Slight movement on fingers present, sensation on foot Case discussed with orthopaedic surgeon and treatment given as per advice.
Advice : do not walk without accompanying person to avoid fall On 18.02.2014 Dr Pramod Kumar Rai , opposite party - 2 advised for MRI of lumbosacral spine being done Arihant Diagnostic Centre which was being got done. The report has made the following impression_ "MRI features of focal increased intramedullary signal intensity in the Conus Medullaris on T2 weighted images at D12-L1 level as described above.
Early lumber spondylitis with mild anterior subluxation of L4 vertebral body with annular bulge L4/5 IV disc with attendant B/L facet joint arthrosis with Hypertrophied Ligamentum Flavum leading to thecal sac indentation with mild B/L neural foramina encroachment ."
It is evident from the MRI report that damage to the spinal cord has been done while doing anaesthesia and the damage caused is so severe that cannot be reverted back to normal functioning of right leg. In the late evening of 19.02.2014 the complainant was discharged for reasons best known. However, the complainant was readmitted in the early morning of 20.02.2014 under opposite party - 2 Dr PB Singh. There was no sensation in the right leg of complainant. The complainant received treatment till 27.02.2014 , however lack of sensation in the right leg continued. The complainant was discharged on 27.02.2014 . Thereafter the complainant went for follow-up to the opposite party - 1 on 29.03.2014 and was referred to Dr Kaushal Agarwal ,orthopaedic surgeon by opposite party - 2. Dr Kaushal Agarwal on examination of the complainant on 29.03.2014 observed -
"Full right foot drop post spinalpain in calftender mild."
Thereafter the complainant got examined herself at Sir SundarlalHospital ,IMS , BHU on 01.05.2014 and on advice, MRI was done at BHU which made the following impression -
"partial disk desiccation at multiple levels with no significant radiculopathy Syrinx formation at D12-L1 level as described above The sensory and motor NCS report conducted at Department of Neurology , BHU dated 01.05.2014 made following conclusions -
SNCS reduced SNAP potential was seen over right sural nerve Incomparison to left sural nerve MNC CMAP amplitude was not recorded over right CPN EPS is suggestive of sensory, motor axonal neuropathy of right lower limb
The complainant thereafter got examined herself in Max Healthcare, New Delhi on 09.05.2014 wherein Dr Amit Batra reported -
" Right lower leg (distal 7 prox) (Post Spinal) advised NW/EMG right lower limb physiotherapy and medication."
Thereafter, the complainant got examined herself in Primus Super Specialty Hospital, Delhi by Dr Kaushal Kishore Mishra on 14.06.2014 , 14.08.2014 and 09.05.2015 . The complainant also got examined herself at Sir Sundarlal Hospital IMS, BHU on various dates and on the advice of Dr Saurabh Singh got her MRI - MID - DORSO -LUMBAOSACRAL SPINE at Nobal Star Diagnostic and Interventional Centre on 07.08.2014 . The report is as follows-
"Cyrinx changes in the spinal cord at D12 Conus Medullary region predominantly right side.
Mild diffuse disc bulge with disc protrusion at L4-L5 , annular bulge at L3-L4 predominantly para posterio-Central resulting compression over the Epidural sac, thecal sac, exiting nerve roots with maintained spinal canal dimension and narrowing at L3-L4 suggested mild proposed intervertebral disc with polyradiculopathy."
The NCV reported 06.08.2014 reported -
MNCV RT PIN, CPN LT PIN CPN TEST: left lower limb nerves are normal. Right CPN nurse are mild discrease, right CPN nurse are neuropathy. Kindly correlate clinically . The NCV reported 07.08.2014 reported - MNCV RT PIN , RT CPN , LTPTN , LT CPN TEST: left lower limb and right PTN nerve are normal, right lower limb CPN nerve are mild discrease , right lower limb CPN nerve are neuropathy. Kindly correlate clinically.
The treatment of the complainant is still continuing. From the facts and treatment records stated and referred to above, it is evident without doubt that Dr Sunita Rai ,oppositw party - 3 anaesthetist was grossly negligent and deficient in administering spinal anaesthesia to the complainant on 15.02.2014 because the anaesthetist made three attempts in administering anaesthetic drug in the spine of complainant. If the spinal needle causes pain, it is obviously correct to avoid injection although it may be too late to prevent nerve damage. The anesthetist intentionally and deliberately avoided to follow up the complainant to know the after effects of the loss caused on account of incorrect and wrong administration of anaesthesia. No radiological means was used by the opposite parties to establish the loss. It is apparent from the post-operative record that a traumatic needle was inserted in Upper lumber interspace which ought to have been avoided . Due to incorrect administration of anaesthesia, post-operative complications developed which are not attended promptly by the surgeon or anaesthetist. The necessary report was prepared after 19.02.2014 & signed in back date. There is interpolation in the size of needle in the anaesthesia report. The anaesthetist did not apply reasonable degree of skill and care while treating the complainant. She did not apply the professional skills. There had been no coordination between the doctors inter se .
On account of incorrect and wrong administration of anaesthesia, the complainant had been continuously suffering since 15.02.2014 , the day she was operated and still suffering. She was compelled to submit her body for various tests in a number of hospitals/diagnostic centres at Varanasi and New Delhi. She is unable to walk of her own and requires an attendant round-the-clock to assist her. She has been compelled to visit various doctors for her examination at Varanasi and New Delhi along with her husband/attendant. Medication and physiotherapy is continuously being done. Her personal privacy has been invaded. She is unable to give comfort to the her family and has become a burden on the family. Her right leg has become weak and fragile. Even after continuous treatment for two years by specialists there is no further recovery in disability and neuropathy of right leg of complainant which has resulted due to negligence of opposite party - 3.She is unable to walk freely as she was walking before operation. She has and is still suffering mental trauma of physical handicapped , financial loss on medication desks, travelling to New Delhi on four occasions with round-the-clock attendant et cetera only on account of gross medical negligence and deficiency in service of opposite parties. A sum of nearly ₹ 5 Lacs have been spent till now by the complainant in the operation, room charges, medicines, tests, travelling, attendant and special diet during her stay in opposite party's hospital and other hospitals. The treatment records including doctor's orders and nurses orders are to be maintained by opposite party - 2 being in the custody of opposite party - 1. The loss suffered by complainant cannot be equated with money however the complainant lodges a claim for compensation treatment expenses et cetera for ₹ 41 lakhs. The complainant claimed the following reliefs-
The opposite parties be directed jointly and severally to pay compensation of ₹ 15 lakhs to the complainant for the loss of her services towards her family and estate due to permanent disability of right leg.
The opposite parties be directed jointly and severally to pay ₹ 10 lakhs to complainant towards doctor's fees, hospital charges, medicines, x-rays, tests, physiotherapy and trending et cetera and for future treatment.
The opposite party be directed jointly and severally to pay ₹ 1 lakh towards extra nourishment to the complainant.
The opposite parties be directed jointly and severally to pay ₹ 10 lakhs to complainant for permanent burning sensation, pain, suffering and disfigurement of right leg.
The opposite parties be directed jointly and severally to pay ₹ 5 Lacs for services of an attendant already obtained and required in whole future life.
The opposite parties be directed jointly and severally to pay interest on the amount awarded.
Such any other and further relief in addition to the release claimed.
The opposite parties no 1 to 3 have submitted their written statement in which they have stated that the answering opposite party - 1 Opal Hospital is a hospital of repute with super speciality service and has been successfully catering medical needs to the patients since last several years. The hospital is a well equipped hospital with vast experienced and highly qualified doctors and paramedical staff. The answering opposite parties, strongly and emphatically denies the false and fabricated allegations of the complainant as being totally misconceived and incorrect factually and medically. The answering opposite party - 2 Dr Pramod Rai is a highly experienced and well qualified doctor in the field of surgery. The answering opposite party - 3 Dr Smrita Rai is a highly experienced and well qualified doctor having specialisation in the field of anaesthesia and successfully completed DM Anaesthesia from Avadesh Pratap Singh University , Rewa in the year 1997. The answering opposite parties stated that the complaint petition filed by the complainant before this Hon'ble Commission is completely misconceived and has been filed by the complainant wrongly.
MrsDamyanti Singh was a 58 years old female who has a long previous history of various medical complications - hypothyroidism, as itself admitted by the complaint petition. Answering opposite party - 2 states that MrsDamyanti Singh was brought to her on 13.02.2014 with the complaint of abdominal and back pain. The opposite party - 2 advised the complainant to conduct certain tests and medication on 13.02.2014 and also advised the complainant to give her post medical treatment record. After seeing all tests reports of complainant on 14.02.14 , she advised the complainant to get herself admitted in the hospital on 15.02.14 . The opposite party - 2 planned the best surgery method -looking the age of the complainant. The opposite party - 3 Dr Smrita Rai did not instruct the complainant to be in supine position because as per the medical protocol. (???) It is not possible to be spinal anaesthesia in the supine position and medication (injection) was given in sitting position and during the medication procedure there was no current like sensation felt by the complainant and in the possession the patient was not caught by any staff. Opposite party - 3 also advised the patient to sit relaxed in bow down position with head down. Opposite party - 3 gave only two pricks for anaesthesia which can happen in even best hands. It is a blind procedure, so more than one prick may be required by most expert hand even. Optimum effect was obtained and surgery was completed smoothly and any complication as alleged by the complainant, is totally baseless and untrue story.
The answering opposite party - 2 and 3, completed the surgery. The complainant did not complain of inability to move her limbs and she was shifted to ward after proper observation of all the vitals like pulse, BP, respiration, oxygen saturation, consciousness. The oxygen saturation was 100% without any external support. The answering opposite parties number 2 and 3 on 15.02 and 16.02.14 did not hear any complaint from the complainant or their attendant. On 17.02.14 one urinary catheter was removed and the complainant was allowed to go to toilet, for the first time the complainant complained about difficulty in walking and putting her foot on ground. It was exactly seen by the opposite party - 2 and opposite parties are raised orthopedic & spine surgeon Dr Kaushal Agarwal to resolve the patient's problem but the answering opposite parties and Dr Kaushal Agarwal did not find any problem and there was never complete loss of sensation and movement in limb (R). There was loss of sensation in particular area and foot drop which is noted in the BHT on 17.12.14. These was diminised (??) the sensation and weakness in L4, L5, S1, S2. The answering opposite parties - 2 and 3 completely denies the relation of the complainant because Dr Kaushal Agarwal is a well qualifiedorthopaedic and spinal surgeon who visited and discussed the patient condition with the opposite parties and for the best interest of the patient advised Solumedral 250 Mg IV , eight hourly and first dose of it was given at 2:30 PM as per the nursing record and next dose was given at 10 PM. After giving first dose of this medicine, the response was very good and patient was able to move on her legs. The answering opposite party 2 and 3 were giving the medication as per the medical protocol but complainant's husband stopped the medication therefore the answering opposite parties - 2 and 3 stop the above corticosteroid drug.
The complainant's husband MrJagdishwarSingh , consulted Dr Rakesh Singh , Neurosurgeon and Dr Shushil Jaiswal , anaesthesist and both the doctors advised the same treatment as given by the answering opposite party - 2 and 3. The answering opposite parties - 2 annual see advised the patient for MRI of lumbo sacral spine, which was done on 18.02.14 . The MRI showed focal increased intra- medullary signal intensity in conus medullaris with early lumbar spondylosis with mild anterior sub luxation of L4-L5 vertebral body with annular bulge at L4-L5 disc with B/L facet joint arthrosis with hypertrophied ligamentum flavum leading to the thecal sac indentation with mild neural foramina encroachment. By MRI report no one can say lesion is because of spinal anaesthesia and cannot be reverse back. There was good response in right foot. The patient could put her heel on ground but there was no response in toes. Patient was feeling better and asked for discharge. The patient was discharged on the request on 19.02.14 morning. She was on only oral medicines and physiotherapy for weakness in the foot, which she could do in her house and feel comfortable in comparison to hospital.
The answering opposite party - 2 emphatically denied the fact that anaesthesia record was already attached to the case sheet that might be unnoticed or deliberately stated anaesthesia record was written on a full BHT , and there was no interpolation in size of needle. It is writing error in case sheet, if case sheet has been written after the complaint, a new sheet without writing error could be attached to, but answering opposite party - 2 neither changed it nor did any interpolation. Answering opposite party - 2 only used two pricks, so only two pricks are written in BHT and it is a blind procedure so more than one prick may be required in even best hands. Complainant's allegation that anaesthesia was given in supine position without understanding its meaning and it is never possible to give the spinal anaesthesia in supine position. The answering opposite parties also state that convent finding in MRI reports, supporting the opposite parties that these changes are not occurred due to the spinal anaesthesia. The medication of opposite parties assured good response in their Rt foot and complainant feeling better and tolerated medicines only but complainant asked for discharge on 19.02.2014 and the answering opposite parties discharge the complainant to take oral medication and physiotherapy for weakness in foot.
The patient developed drug induced nausea and vomiting on 20.0 2.2014 morning. As per advice of Prof PB Singh the patient was again admitted for IV medication. Opposite party - 2 and MrJagdishwar Singh discussed the case with Prof PB Singh (Consultant-Urologist , Max Hospital) as a friend and well-wishers to take expert opinion from Max Hospital. He discussed with his colleague orthopaedic surgeon, neurosurgeon and anaesthesist is to and advised to give injection Solumedral (Corticosteroid) for three days again which we have already started earlier and then discharged on oral tablets. On 22.02.2014 the patient felt better, there was no nausea and vomiting. Power in right foot and toes improved. Sensation was also improving significantly. On 24.02.2016 , the patient was seen by Dr RP Singh , Neurosurgeon. He examined and found the patient was putting heel on ground and started walking. Then he added some medicines are (neuro tonics). Patient was also seen by neurologist Dr Avinash Singh and was advised to continue the same treatment.
As per the medical protocol, it is not possible to give spinal anaesthesia in the supine position and medication (injection racket was given in sitting position and during the medication procedure there was no current like sensation felt by the complainant the patient was not caught by any staff. The opposite party - 3 also advised the patient to sit relaxed in bow down position with neck down. Opposite party - 3 used only two pricks for anaesthesia which can happenin best hands. It is blind procedure, so more than one prick may be required by most expert hand even. Optimum effect was obtained and surgery was completed smoothly which any complication as alleged by the complainant is totally baseless and untrue story. The medicines were given as per medical protocol. Answering opposite party - 2 emphatically denied the fact that anaesthesia record was already attached to case sheet that might be unnoticed or deliberately stated that anaesthesia record was written on a full BHT and there was no interpolation inside of needle. Answering opposite party - 2, on the user two pricks so only two pricks is written in BHT. It is well settled law that if the doctor performed his duty with reasonable care, there shall be no medical negligence and in this case doctors perform these duties with reasonable care so there is no medical negligence on the part of the opposite parties.
got admitted herself that she had the problem of minor hypothyroidism. The opposite parties are also stated the same problem of the complainant. It is to be seen whether minor hypothyroidism is curable or not and whether it has any effect on the anaesthesia administration. Hypothyroidism is a condition where there isn't enough thyroid hormone in your bloodstream and your metabolism slows down.
Hypothyroidism happens when your thyroid doesn't create and release enough thyroid hormone into your body. This makes your metabolism slow down, affecting you entire body. Also known as underactive thyroid disease, hypothyroidism is fairly common.
In general, hypothyroidism is a very treatable condition. It can be managed with regular medications and follow-up appointments with your healthcare provider.
Hypothyroidism can affect people of all ages, genders and ethnicities. It's a common condition, particularly among women over age 60. Women are generally more likely to develop hypothyroidism after menopause than earlier in life.
In most cases, hypothyroidism is treated by replacing the amount of hormone that your thyroid is no longer making. This is typically done with a medication. One medication that is commonly used is called levothyroxine. Taken orally, this medication increases the amount of thyroid hormone your body produces, evening out your levels.
Hypothyroidism is a manageable disease. However, you will need to continuously take medication to normalize the amount of hormones in your body for the rest of your life. With careful management, and follow-up appointments with your healthcare provider to make sure your treatment is working properly, you can lead a normal and healthy life.
Hypothyroidism produces major derangements of normal physiology. Depression of myocardial function, decreased hypoxic and hypercapnic ventilatory responses, abnormal baroreceptor function, and reductions in plasma volume may all be present. In addition, the presence of anemia, hypoglycemia, hyponatremia, decreased free water excretion, and impaired hepatic drug metabolism may all adversely influence responses to anesthesia. Most reported complications have occurred in patients with unrecognized hypothyroidism. Preoperative recognition of hypothyroidism is essential for the safe anesthetic management of these patients. Elective surgical procedures should not be undertaken in the presence of untreated hypothyroidism. Thyroid supplements should be untreated hypothyroidism. Thyroid supplements should be given preoperatively to hypothyroid patients before emergency surgery. Intraoperative and postoperative hypothermia and electrolyte disturbances are relatively common and must be guarded against. So in such cases preoperative precautions should be taken by the concerned Dr before administering anaesthesia. So this is not a challenging are fatter factor for operation or administering anaesthesia.
In this case everything is admitted. Admission in the hospital, giving of spinal anaesthesia, development of complication as a consequence of anaesthesia et cetera. First of all we will see the position in which anaesthesia was given to the patient. The complainant has stated that the anaesthesia was given to her in supine position while the opposite parties have reiterated that the anaesthesia was given in sitting position. We should know the position during anaesthesia and which position is the best position for giving anaesthesia and whether in the present case the anaesthesia was given in supine position or in sitting position.
Once the patient has undergone appropriate selection, the optimal patient position for the procedure must be established.
The procedure is usually carried out with the patient in the sitting or lateral decubitus position. The patient's comfort is tantamount. The goal of positioning is to help establish a straight path for needle insertion between the spinal vertebrae. The most commonly used position is the sitting position. This is because, in the lateral decubitus position, the spinal anatomy is usually not laterally symmetrical as it is in the sitting position.
With the patient positioned in the sitting position and leg hanging from the side of the bed, he/she should be encouraged to maintain a flexed spine position to help open up the interspace. The sitting position is appropriate for spinal anesthesia with a hyperbaric solution.
Either left or right lateral decubitus positions are viable options as well.
After the patient is in the proper position, the access site is identified by palpation. This is usually very difficult to achieve with obese patients because of the amount of subcutaneous fat between the skin and the spinous process. The space between 2 palpable spinous processes is usually the site of entry. The patient should wear a hat or cover for his/her hair to maintain asepsis.
Strict aseptic technique is always necessary, achievable with chlorhexidine antiseptics with alcohol content, adequate hand-washing, mask, and cap. Cleaning always starts from the chosen site of approach in circles and then away from the site. Allow time for the cleaning solution to dry. In the spinal kit, the drape placement is on the patient's back to isolate the area of access. Local anesthetic (usually about 1 ml 1% lidocaine) is used for skin infiltration, and a wheal is created at the site of access chosen, either midline or paramedian.
In the midline approach, the spinal approach to the intrathecal space is midline with a straight line shot. After infiltration with lidocaine, the spinal needle is introduced into the skin, angled slightly cephalad. The needle traverses the skin, followed by subcutaneous fat. As the needle courses deeper, it will engage the supraspinous ligament and then the interspinous ligament; the practitioner will note this as an increase in tissue resistance. Next later will be the ligamentum flavum, and this would present like a "pop." On popping through this ligament, is the approach to the epidural space, which is the point of placement for epidurally-administered medications and catheters. This also presents the point where the loss of resistance is felt to the injection of saline or air. For spinal anesthesia, the clinician proceeds with needle insertion until penetration of the dura-subarachnoid membranes, which is signaled by free-flowing CSF. It is at this point that the administration of spinal medication takes place.
For the paramedian approach, the skin wheal from the local anesthetic is placed about 2 cm from the midline, and the spinal needle advances at an angle toward the midline. In this approach, the supraspinous and interspinous ligaments are usually not encountered. Hence, there is little resistance encountered until reaching the ligamentum flavum.
Complications Appropriate patient selection and care should be established to help obviate common complications associated with neuraxial anesthesia. While many of the complications are of very low incidence, it's worth being aware of them. Severe complications are believed to be extremely rare, but the frequency is probably underestimated. Some common ones are:
Backache (more common with epidural anesthesia) Postdural puncture headache (as high as 25% in some studies). A non-cutting needle should be utilized for patients with high risk for PDPH, and the smallest gauge needle available is the recommendation for all patients Nausea, vomiting Hypotension Low-frequency hearing loss Total spinal anesthesia (most feared complication) Neurological injury Spinal hematoma Arachnoiditis Transient neurological syndrome (especially with lidocaine) surgical procedure is safe and effective. Determining a patient's position for a procedure is determined from a preoperative assessment and is based on factors like the type of procedure, length of procedure, patient's ability to tolerate the procedure, exposure required by the surgical team, anesthesia access, among others.1 One of the four basic patient positions during surgery is the supine position.
WHAT IS THE SUPINE POSITION?
The supine position is one of the four basic patient positions. The three other positions are prone, lateral, and lithotomy. In supine position, the patient is face up with their head resting on a pad positioner or pillow and their neck in a neutral position. The patient's arms, maintained in a neutral thumb-up or supinated position, may be tucked at their sides or abducted to less than 90 degrees on armboards.2 WHEN TO USE SUPINE PATIENT POSITIONING Supine patient positioning is used for intracranial procedures as well as procedures on the anterior surface of the body. Also known as Dorsal Decubitus, procedures that typically use the supine position include:
Cardiac Colorectal Thoracic Abdominal Abdominothoracic Endovascular surgeries Laparoscopic surgeries Upper extremity surgeries including hand and wrist Lower extremity surgeries including hip, knee, foot, and ankle Procedures on the neck and face are also often performed in supine position, as well as plastic surgeries and general surgeries.
As with all surgical positions, surgical staff should be aware of risks to the patient in the supine position.
One such risk involves the patient's respiratory functions. When a patient is placed from an upright to a supine position, the intra-abdominal organs shift cephalad, compressing the adjacent lung tissue and potentially leading to decreased functional residual capacity (FRC).2 The supine position also causes extra pressure on the skin and bony prominences over the occiput, scapulae, elbows, sacrum, coccyx, and heels. Surgical table pads and patient positioning pads should be used to reduce the risk of pressure sores and ulcers. Additionally, the brachial plexus and ulnar nerves need to be protected in supine position by having armboards level with the operating table pad and a 90-degree extension of the arms with palms facing up.3 BENEFITS OF THE SUPINE POSITION The supine position is one of the most natural positions for patients and usually allows for all patient anatomical structures to remain in natural neutral alignment. Most patients are able to maintain adequate respiratory function with no constricting external compression on the respiratory system. The supine position allows for excellent access to the anterior structures of the body. Also, the supine position is one of the safest positions for stability on the surgical table. It is easy to ensure that patient safety straps are placed and with the entire body supported the risk of injury from falling is further reduced.
SUPINE POSITION VS. SEMI SUPINE POSITION Semi supine position refers to positions where the patient is lying on the surgical table but with additional articulations. These are commonly referred to as:5 Lawn chair position: A variation where the hips and knees are slightly flexed and above the level of the heart. This position can alleviate pressure on the patient's back, hips, and knees. Lawn chair position may be used to assist with relieving tension on abdominal structures and drainage from the lower extremities of venous blood.
Frog-leg position: A variation where hips and knees are flexed, and the hips are externally rotated. This may be necessary to access anatomies such as the groin, rectum, and inner thigh. Ensure the patient's knees are supported to avoid stress on the hips.
ALTERNATE POSITIONS TO THE SUPINE POSITION Alternate positions of the Supine position typically include tilting the patient in various planes. These position alternatives include:
Trendelenburg position: A variation of the supine position in which the patient's head is tilted down so that the patient's abdominal organs are moved towards the head, improving surgical access to the pelvic organs.1,2 Reverse Trendelenburg position: A variation of the supine position in which the patient's head is tilted upward so that their feet are positioned down. Reverse Trendelenburg may be used for stomach, gallbladder, and biliary tract surgeries.
Fowler's position: This is the most common position for patient resting comfortably, whether in-patient or in the emergency department. In this position, the patient's knees are either straight or slightly bent and the head of the bed is angled between 45 and 60 degrees. Respiratory changes result in increased oxygenation by maximizing chest expansion, minimizing abdominal muscular tension, and minimizing the effects of gravity on the chest wall; therefore, a useful maneuver for patients in mild to moderate respiratory distress.
High Fowler's position: This position, with the head of the bed between 60 and 90 degrees, is useful during the placement of orogastric and nasogastric tubes as it decreases the risk of aspiration. Also known as beach chair position, this variation of the supine position has the patient sitting with their hips and knees and slightly flexed and above heart level to relieve pressure on the back, hips, and knees. This position facilitates venous drainage from the lower extremities and reduces tension on the abdominal muscles.4 Fowler's position is commonly used during neurosurgery and shoulder surgeries.
CONCLUSION A very common patient position, the supine position allows for ideal surgical access for intracranial procedures and surgery on the anterior cervical spine.2 Surgical staff should consider risks and complications associated with the supine position such as decreased functional residual capacity and risk of pressure sores from increased pressure on the bony prominences on the patient's body. Variations to the supine position include Trendelenburg position, reverse Trendelenburg position and Fowler's position.
Regardless of what position is being used for a patient during a procedure, it's important to follow best practices for positioning.1 Having an adequate number of personnel, devices, and equipment available during positioning activities helps to ensure patient and personnel safety Respect the patient's dignity and privacy during positioning. Only necessary personnel in the room with the patient is exposed.
Maintain the patient in a natural neutral alignment. Keep the patient's head and neck is in a neutral position without extreme lateral rotation and avoid hyperextending.
Verify the patient's complete body is in physiologic alignment and that the hands, fingers, feet, and toes are protected from surgical table articulations.
Operating Room staff should always use safe body mechanics during transfers and positioning.
Ensure that the patient is not in contact with any metal portions of the surgical table or positioning devices.
Never exceed the weight limits for the table or the accessories used and always follow the manufacture's guidelines and recommendations when using the surgical table and accessories.
Inspect all equipment, pads and accessories and replace them as needed.
Which is the best position for spinal anaesthesia:
Introduction The positioning of a patient is one of the major factors contributing to the success of a neuraxial block; other factors include the ease of identifying anatomical landmarks including the midline and interspinous space, and the anesthesiologist's level of experience.1 The quality of positioning was defined as good or poor according to the ability to flex the spine adequately. Poor positioning leads to multiple attempts for the intervention due to needle - bone contact (NBC), which may result in back pain, hematoma, and paresthesia.2 The conditions may cause dissatisfaction and cause the patient to refuse the procedure.3, 4 A flexed back and reduced lumbar lordosis are considered to be necessary for optimal positioning in either the sitting or lateral decubitus positions. These maneuvers widen the interspinous space and push the thecal sac into a more superficial position.3, 4 The traditional sitting position (TSP) is the most common position for spinal or epidural anesthesia where the patient sits on the operating table, with both feet placed on a stool, and both hips and knees maximally flexed (Fig. 1). Four decades ago, a new sitting position was introduced to reduce lumbar lordosis for "easier" spinal puncture; this position involved maximum extension of the knees, adduction of the hips, and forward bending.5 Based on this idea, modified sitting positions have been introduced for spinal or epidural anesthesia. In these positions, the patients are sat up on the operating table, but the legs remain on the table, which is different from the TSP. In the hamstring stretch position (HSP), the knees are maximally extended (Fig. 2), whereas in the squatting position (SP), both the hips and knees are maximally flexed (Fig. 3).6, 7, 8 Similar success rates have been reported in studies comparing TSP with modified sitting positions for epidural or spinal anesthesia.6, 7, 8 However, to the best of our knowledge, this issue has not been previously investigated for combined spinal - epidural anesthesia (CSEA) with the aim for reducing needle - bone contact events and for increasing the success rate of the intervention. CSEA is frequently used in orthopedic lower limb surgery because it provides motor and sensory blocks by the spinal anesthesia component, while indwelling an epidural catheter enables the modification of the block and postoperative analgesia.9 Figure 1. Traditional sitting position. The picture shows the positions of the patient, the nurse anesthetist, and the anesthesiologist.
Figure 2. Hamstring stretch position. The picture shows the positions of the patient, the nurse anesthetist, and the anesthesiologist.
Figure 3. Squatting position. The picture shows the positions of the patient, the nurse anesthetist, and the anesthesiologist.
The aim of this study was to test the hypothesis that modified sitting positions including hamstring stretch position and squatting position would reduce needle - bone contact and increase the success rate of the needle - through - needle technique combined spinal - epidural anesthesia (CSEA) compared to traditional sitting position in patients undergoing total knee or hip arthroplasty.
Methods This was a prospective, multi-centered and multi-arm parallel randomized clinical trial. The trial was approved by the hospital's ethics committee (04.16. 2018-49/08). A written informed consent was obtained from all subjects participating in the trial. The trial was registered at ClinicalTrials.gov (http://clinicaltrials.gov), (NCT03541798, date of registration: May 1, 2019) prior to patient enrollment. This manuscript adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement.10, 11, 12 The trial ended after the pre-planned number of patients concluded the intended follow-up period. Patients were randomly assigned to one of three parallel groups, initially in 1:1:1 ratio to receive CSEA in three different sitting positions. It was decided that the patients were dropped out after trial commencement who could not tolerate their position or developed sudden deterioration in vital parameters during the intervention which required emergency treatment.
The inclusion criteria were as follows: American Society of Anesthesiologists (ASA) physical status class I-III patients, aged between 40 and 85 years, scheduled for elective unilateral total hip or knee arthroplasty under combined spinal - epidural anesthesia were enrolled in the study.
The exclusion criteria were patient refusal, history of previous lumbar surgery, neurological disease, obvious lumbar scoliosis, the inability to flex the knees, coagulation disorders, and trauma surgery.
The trial was conducted in the orthopedic operating theatres of two academic training and research hospitals and of a tertiary hospital. Five staff anesthesiologists with more than ten years of experience in regional anesthesia participated in the study who performed more than 500 combined spinal - epidural anesthesia procedures in traditional sitting position and hamstring stretch position. Patients were invited on the day before the surgery. Saline or Ringer's lactate solution (1-3 mL.kg-1.h-1, up to 1 L) was intravenously (IV) administered for hydration during the fasting period, which lasted six hours for light meals and two hours for clear fluids. Two milligrams of IV midazolam was administered as the premedication before the patients were transferred to the operating room. After arriving in the operating room, the patients were monitored with noninvasive blood pressure, pulse oximetry, and electrocardiogram equipment. Patient characteristics including sex, age, weight, height, and body mass index (BMI) were recorded. Patients were randomly assigned to one of three parallel groups in 1:1:1 ratio to receive CSEA in three different sitting positions: the traditional sitting group (Group TSP, n = 120), the hamstring stretch group (Group HSP, n = 120), and the squatting group (Group SP, n = 120). Patients in group TSP were placed in a sitting position with their legs on a stool at the edge of the operation table, their knees flexed to 90°, and their hips adducted (Fig. 1). Patients in group HSP were seated with their lower extremities placed on the operation table, knees in maximum extension, hips in adduction, and trunk leaning forward (Fig. 2). In group SP, the patients were seated on the operation table with their hip and knee joints flexed. The patients hugged their knees, and both the buttocks and plantar surfaces of the feet were supported by the operating table (Fig. 3). A nurse anesthetist helped support the patients from the ventral side for TSP and from the lateral side for HSP and SP; the nurse held their posture by holding their shoulders. All patients were asked to bend forward and flex their back as much as they could tolerate. The patient's back was facing the anesthesiologist performing the procedure and the anesthesiologist sat on a stool behind the patient at a level where he/she could easily observe the patients' back (Figure 1, Figure 2, Figure 3). After the patients were positioned, the anesthesiologist graded the ease of the identifying the interspinous space using palpation of the adjacent lumbar spinous processes on a 3-point scale: easy = both adjacent spinous processes are palpable, difficult = one of the adjacent spinous processes is palpable, and impossible = both adjacent spinous processes are impalpable. Two interspinous spaces (the first and second) were selected from the L2-L3, L3-L4, and L4-L5 intervertebral levels to undergo CSEA.
After sterile preparation and dressing, the skin and subcutaneous tissue were infiltrated with a local anesthetic (3 mL of 2% lidocaine). CSEA was performed at the first interspinous space with a midline approach using a CSEA set (B. Braun Melsungen AG, Germany) that contains an 18 gauge (G) Tuohy epidural needle, a 27 G Whitacre spinal needle, and an epidural catheter.
The Tuohy needle was introduced in the midline at the interspinous space and directed slightly cephalad. The epidural space was located with the loss of resistance to the saline technique. Then, the spinal needle was advanced through the epidural needle until it penetrated the dura mater with the distal aperture facing the cephalad (needle -through- needle technique). Following this, 3-3.5 mL of 0.5% hyperbaric bupivacaine (15-17.5 mg) was administered after obtaining of free flow of cerebrospinal fluid through the spinal needle. The spinal needle was withdrawn, and an epidural catheter was inserted 4 cm into the epidural space and secured. The case was termed "Success at First Try". When a bone contact occurred, the Tuohy needle was withdrawn to subcutaneous tissue. It was redirected cephalad, horizontal or caudad. A maximum of three redirections were allowed. If the epidural space was located, spinal anesthesia and epidural catheter placement were performed as described. The case was termed "Success after Needle Redirection". However, the epidural needle was withdrawn after three failed redirections. A new puncture site was not allowed at the same level. The case was then termed "Failed CSEA at the First Intervertebral Space".
At this stage, a second attempt was carried out at the second interspinous space with the same approach that was used for the first attempt. If the attempt was successful without needle bone contact, the case was termed "Success at the Second Intervertebral Space". If the second attempt also failed, the case was recorded as a "Failed CSEA for the Position" case and the study was stopped. At this stage, the patients were directed to the following options: a) a spinal anesthesia was attempted using a 27 G spinal needle (B.BraunMelsungen AG, Germany). If the spinal anesthesia was successful, the case was termed "Failed CSEA, Successful Spinal Anesthesia". If spinal anesthesia was failed too, general anesthesia was induced. b) In the case of successful location of epidural space with Tuohy needle but of failure of spinal anesthesia using needle - through - needle technique, the epidural catheter was inserted into epidural space and a spinal puncture was attempted using a 27 G spinal needle at an inferior level. If spinal anesthesia was successful, the case was termed as "Successful CSEA with Separate Level - Separate Needle Technique". If spinal anesthesia was failed, general anesthesia was induced.
The primary outcome measures were the number of needle-bone contact (NBC) events and success rate of CSEA. The secondary outcome measure was the grade of interspinous space identification. The correlation between the grade of interspinous space identification and success rate was also investigated. The grade of interspinous space identification, number of NBC events, and success rates were compared between different BMI classes to find out whether a relationship exist between BMI and determinants of the intervention. Success of the intervention was modeled using univariate and multivariate logistic regression models with respect to sitting positions, body mass index classes, and ease of intervertebral space identification. In previous studies, the success rate of needle insertion without NBC has been reported to be 50% in traditional sitting position, 60% in the hamstring stretch position and, 70% in the squatting position.4, 6 A power analysis revealed that a minimum sample size of 110 patients per group was needed to achieve a power of 0.8 (80%) with a confidence level of 95%.13 It was aimed to enroll 360 patients (120 in each arm) to allow withdrawal or loss to follow- up rate of 10%.
Randomization was performed with computer-generated simple random sequence to assign patients to one of three study arms. Allocation concealment was achieved by means of sealed, opaque and continuously numbered envelopes, which were matched with patients according to their order of inclusion in the study. The study coordinator (MÖÖ) was responsible for the generation of the random sequence and for its concealment in opaque, numbered envelopes. A research assistant enrolled the participants and allocated each patient to the next sealed envelope containing the information on the randomized group. The envelopes were opened by the anesthesiologist before the intervention who performed CSEA.
The following parameters were recorded and compared between the study groups: demographic characteristics, grade of intervertebral space identification, number of needle - bone contact events, number of successful and failed cases of combined spinal - epidural anesthesia, and complications.
Statistical analysis The data were analyzed using IBM SPSS Statistics version 21 (IBM SPSS Inc, Chicago, IL) pocket program. The descriptive statistics calculated for the continuous variables were the mean, and standard deviation (mean ± SD), and those for the categorical variables were the frequency distribution and percentage (n, %). Pearson's chi-square (χ2) test was used to assess the differences in distributions of the categorical variables between groups. The normality of the data was assessed with the Kolmogorov - Smirnov test. Differences in the non-normally distributed variables between groups were assessed with Kruskal - Wallis variance analysis.14 The variables which will be included in multivariate logistic regression model were described by univariate logistic regression analysis using Wald statistics.15 The variables with Wald p values < 0.25 were included in the multivariate model. The p value of the sitting positions was > 0.25, so the sitting positions were not included in the multivariate model. p < 0.05 was considered statistically significant for all tests.
Results A total of 360 patients were included in the study. There were 201 (55.8%) female and 159 (44.2%) male patients. The mean age was 68.29 ± 7.40 years. Seven patients (5.8%) in group SP and 4 patients in group HSP (3.3%) could not tolerate their position during the intervention due to discomfort and pain at the knee or hip. These eleven patients were excluded from the study and general anesthesia was induced. The procedure was well - tolerated by all the patients in group TSP. The data from remaining 349 patients were available for the intention-to-treat analysis. Fig. 4 shows the flow diagram of participants through each stage of the study. Patient recruitment happened between May 2, 2019 and December 23, 2019 and patients were followed-up for 3-5 days after surgery. The trial ended after the pre-planned number of patients who concluded the intended follow-up. The demographic data were comparable across the three study groups (Table 1).
Figure 4. Diagram showing the flow of participants through each stage of the trial.
Table 1. Patient baseline characteristics and features of surgical procedures performed according to treatment group.
Baseline characteristics Group TSP (n = 120) Group HSP (n = 116) Group SP (n = 113) p Age (years)a 68.3 (7.5) 67.9 (7.3) 68.4 (7.5) 0.815 Gender (n) Female/Male 68 / 52 63 / 53 64 / 49 0.917 Body Mass Index Classb (kg.m-2) Underweight 9 (7.5%) 11 (9.5%)
10 (8.8%) 1.000 Normal 39 (32.5%) 37 (31.9%) 36 (31.9%) Overweight 35 (29.2%) 33 (28.4%) 32 (28.3%) Obesity class I 22 (18.3%) 20 (17.2%) 21 (18.6%) Obesity class II 11 (9.2%) 12 (10.3%) 10 (8.8%) Obesity class III 4 (3.3%) 3 (2.6%) 4 (3.5%) ASA status (n) I / II / III 51 / 56 / 13 49 / 55 / 12 50 / 50 / 13 0.992 Arthroplasty (n) Hip / Knee 79 / 41 79 / 37 68 / 45 0.434 TSP, traditional sitting position; HSP, hamstring stretch position; SP, squatting position; ASA, American Society of Anesthesiologists physical status classification.
p < 0.05 was considered as statistically significant.
a Data presented as mean (standard deviation).
b Data presented as absolute number (%).
Primary outcome measures The overall success rate of CSEA was 93.3% in the remaining 349 patients. When the success rates were compared between study groups, it was found that the success rate was the highest in group TSP and the lowest in group SP, but this difference was not statistically significant (93.3% vs. 92.2% vs. 92.0%; p = 1.000), (Table 2).
Table 2. Comparison of study groups regarding number of needle bone contact, success of the intervention and ease of intervertebral space identification.
Variable Group TSP (n = 120) Group HSP (n = 116) Group SP (n = 113) p Needle Bone Contacta 0 59 (49.2%) 56 (48.3%) 55 (48.7%) 0.997 1 26 (21.7%) 25 (21.6%) 25 (22.1%) 2 2 (1.7%) 1 (0.9%) 1 (0.9%) 3 21 (17.5%) 19 (16.4%) 19 (16.8%) 4 4 (3.3%) 5 (4.3%) 4 (3.5%) 5 0 (0.0%) 1 (0.9%) 0 (0.0%) 6 8 (6.6%) 9 (7.8%) 9 (8.0%) Successa at First Try 59 (49.2%) 56(48.3%) 55 (48.6%) 1.000 After Needle Redirection 28 (23.3%) 26 (22.4%) 26 (23.0%) at Second Intervertebral Space 25 (20.8%) 25 (21.5%) 23 (20.4%) Overall 112 (93.3%) 107 (92.2%) 104 (92.0%) Failed CSEA 8 (6.7%) 9 (7.8%) 9 (8.0%) Ease of Inter-
Vertebral Space Identificationa Easy (n = 206) 69 (57.5 %) 70 (60.3%) 67 (59.3 %) 0.995 Difficult (n = 115) 41 (34.2 %) 37 (31.9%) 37 (32.7 %) Impossible (n = 28) 10 (8.3%) 9 (7.8%) 9 (8.0%) TSP, traditional sitting position; HSP, hamstring stretch position; SP, squatting position; NBC, needle bone contact; CSEA, combined spinal epidural anesthesia.
p < 0.05 was considered as statistically significant.
a Data presented as absolute number (%).
The success rates "at First Try" (NBC = 0), " after Needle Redirection" (NBC = 1 or 2), and "at the Second Level" (NBC = 3-5) were also similar between the three groups (p = 1.00, Table 2). Needle - through - needle technique CSEA failed in 26 patients (7.45%). The rate of "Failed CSEA for the Position" (NBC = 6) was statistically similar between the TSP, HSP, and SP groups (6.7% vs. 7.8% vs. 8%, respectively; p = 1.00). Spinal anesthesia was successful in three patients of group TSP, in two patients of group HSP, and in three patients of group SP. The remaining eighteen patients received general anesthesia.
Secondary outcome measures Interspinous space identification was identified easy in 59.0%, difficult in 33.0%, and impossible in 8.0% of all patients. The grades of interspinous space identification were not statistically different among the three groups (p = 0.990). There was a correlation between the grade of interspinous space identification and success rates of the intervention (p < 0.001). The success rate at first try was significantly higher in patients whose interspinous space was considered easy to identify than in patients whose interspinous space was considered difficult or impossible to identify (73.3% > 16.5% > 0.0%; respectively, p < 0.001). The rate of failed CSEA also increased as the identification of interspinous space became more challenging (easy (1.0%) < difficult (10.4%) < impossible (42.9); p < 0.001). It was found that the rate of "easy" interspinous space identification significantly decreased as the body mass index increased (100% > 97.3% > 51% > 15.0%; p < 0.001). The grade of interspinous space identification was impossible in 26.1% of obese patients versus 0% in non-obese patients. On the other hand, the first try success rate (NBC = 0) was the highest in patients with a normal body mass index but the lowest in obese patients (p < 0.001). However, the logistic regression analysis revealed that the sitting positions and body mass index were insignificant factors in the success of the CSEA. In contrast, the ease of interpinous space identification was a significant factor (p < 0.001) (Table 3).
Table 3. Relationship of body mass index and ease of interspinous space identification to the success rate of the intervention, multivariate logistic regression model.
Variables Regression coefficient Standard error Wald's χ2 valuea 95% CI of OR p Empty Cell Empty Cell Empty Cell Empty Cell OR Lower Upper Empty Cell Body Mass Index Normal weight Reference
-
0.40
-
-
-
0.940 Under weight
-17.196
-16.913 0.00 0.000 0.000
-
0.998 Overweight
-18.451
-16.411 0.00 0.000 0.000
-
0.998 Obese
-19.605
-16.192 0.00 0.000 0.000
-
0.998 Ease of Intervertebral Space Identification Easy Reference
-
15.640
-
-
-
< 0.001 Difficult
-2.475
-2.740 6.165 0.065 0.007 0.562 0.013 Impossible
-4.337
-4.23 14.866 0.009 0.001 0.098 < 0.001 CI, confidence interval, OR, odds ratio.
p < 0.05 was considered statistically significant.
a The variables with a Wald's χ2 value > 0.25 were included in the multivariate model.
A total of 24 (6.87%) complications were observed and treated throughout the study period. Eight adverse events occurred in each group (p = 1.000). For the TSP, HSP, and SP groups, the adverse events were back pain (3, 2, and 2 cases, respectively), hypotension (4, 5, and 4 cases, respectively), bradycardia (1, 0, and 1 case, respectively), and unintentional dural puncture (0, 1, and 1 case, respectively); (p = 1.000).
Discussion The results of the study demonstrated that the success rate of CSEA and the number of needle - bone contact events were not different between the traditional sitting position and modified positions, including the hamstring stretch and squatting positions. The ease of the interspinous space identification was also similar across the positions. Based on the data in the present study, it can be stated that hamstring stretch and squatting position can be used as alternative positions to the traditional sitting position in patients undergoing knee or hip arthroplasty under combined spinal-epidural anesthesia. This statement is consistent with the results of few studies comparing modified sitting positions with the traditional sitting position for epidural or spinal anesthesia.6, 7, 8 In an earlier study, the number of needle - bone contact events and failure rates were found to be similar between the HSP and TSP positions and it was stated that the HSP increased lumbar flexion but also created tension in the supraspinous ligament which led to interspinous depression.5 In another study, the traditional sitting position was compared with the squatting position in patients undergoing lower abdominal or extremity surgery under spinal anesthesia. The number of needle-bone contact events was lower in the squatting group although the ease of interspinous space identification and success rates were similar. It was concluded that this difference favoring the squatting position may be due to the induced tension in the supraspinous ligament.7 In another study, there was not a significant difference in the number of needle - bone contact events, grades of interspinous space identification or success rates among patients who were positioned in the TSP, HSP and SP for spinal anesthesia.8 However, the overall success rates in those studies ranged between 98.3% and 99.0%, which was higher than that in our study (92.0%-93.3%). This discrepancy may be explained by the differences between our study and other studies in the literature:
a) The patients in this current study groups were older (68.29 ± 7.40 years) than those included in other studies (between 40.4 ± 0.8 years and 48.8 ± .8.6 years.6, 7, 8 It is well known that degenerative spine conditions are common in older patients and cause a gradual loss of a normal spine structure and function over time. General symptoms include spinal deformity, limited motion and chronic pain with movement, which may make the neuraxial procedure more difficult to perform.
b) Obese patients were included in our study. In other studies, patients with a body mass index higher than 32, 35 and 40 kg m-2 were excluded.6, 7, 8 The body mass index was between 35 and 39.9 kg m-2 in 33 (9.2%) patients and was higher than 40 kg m-2 in 11 (3.1%) patients in the current study. When the success rates and number of needle-bone contact events were compared between different body mass index classes, it was found that the success rate was lower and the number of needle-bone contact events was higher in patients with higher body mass index. Additionally, interspinous space identification was also considered difficult in overweight patients and impossible in obese patients which increased the failure rate. It was reported that patient's age greater than 65 years and BMI > 30 kg m-2 are associated with poor positioning which result in having difficulty in adequately flexing the lumbar spine.1 The findings in the current study are consistent with those in reports that revealed that a higher body mass index is associated with the difficulty in performing the neuraxial intervention due to an increased lumbar epidural depth and poor visibility of the landmarks used for interspinous space identification.5, 7, 8, 16,17 However, it should be noted that BMI was not found as a significant factor in the success rate of the intervention according to logistic regression analysis.
c) A combined spinal - epidural anesthesia technique was used in our study. Although failures might be caused by similar issues in separate level - separate needle CSEA technique and spinal or epidural anesthesia, the needle - through - needle combined spinal - epidural anesthesia technique has specific mechanisms as the failure to penetrate dura mater due to the inadequate advancement of a short spinal needle that is too short, failure to stabilize the fine spinal needle, and deviation of from the midline during local anesthetic administration.9 It was observed that four patients in group HSP and another seven patients in group SP could not tolerate their position due to pain during the procedure whereas no patient in group TSP. The pain might be unbearable with maximum extension or flexion of the knees in patients with degenerated joints, as the positions stretch the muscles. It has been reported that muscle impairments and pain in patients with osteoarthritis are not only limited to the quadriceps but also involve the hamstring and hip muscles.18, 19 This study has several limitations: a) the block performers could not be blinded to the positioning b) they did not have sufficient experience to perform CSEA in the squatting position, and c) the grading of interspinous space identification was subjective.
Ultrasonography has gained popularity in recent years as a useful tool for clinical examinations when performing central neuraxial blocks. It provides objective information including the depth of the epidural space, and the location of the midline and interspinous spaces.20, 21 It is concluded that both the squatting and hamstring stretch positions may be used as alternative positions to the traditional sitting position for combined spinal - epidural anesthesia in patients undergoing hip or knee arthroplasty because of the similar success rates, number of needle - bone contact events, and grades of interspinous space identification. However, it should be noted that patients with degenerated knee or hip joints may have intolerance to modified sitting positions due to pain. The body mass index and the grade of intervertebral space identification may be important determinants of combined spinal - epidural anesthesia success. Additional studies using radiologic imaging or ultrasound are required to identify more objective measurements that predict difficulty of performing combined spinal - epidural anesthesia.
Registration The trial was registered prior to patient enrollment at ClinicalTrials.gov (http://clinicaltrials.gov), (NCT03541798, principal investigator: Ceyda OzhanCaparlar, date of registration: May 1, 2019).
Conflict of interest The authors declare no conflicts of interest.
Abstract Seven hundred thirty ambulatory surgery patients, randomly assigned to receive spinal anesthesia with a 26- or 27-G needle, were studied for the incidence of post-dural puncture headache (PDPH), postoperative back pain, and patient acceptance. The incidence of PDPH following the use of 26- and 27-G needles was 9.6% and 1.5%, respectively (P less than 0.05). The incidence of PDPH was 5.7% among men and 13.4% among women following the use of 26-G needles (P less than 0.05), whereas no difference between men and women was noted after the use of 27-G needles. Of the patients who were 40 yr of age or younger, the overall incidence of PDPH was 11.9%, with a 7.5% incidence among men and a 16.4% among women following the use of 26-G needles (P less than 0.05) and a 1.8% incidence of PDPH following the use of 27-G needles, with no statistical difference between genders. Postoperative back pain was experienced in 18.3% of the patients in the 26-G group and 20.2% in the 27-G group (difference not significant). Favorable acceptance of spinal anesthesia was reported in 89.4% of patients in the 26-G group and 98.2% in the 27-G group (P less than 0.01). Results from this study demonstrate that, in patients who received spinal anesthesia for ambulatory surgery, the use of 27-G needles resulted in a significantly lower incidence of PDPH and greater patient acceptance compared with the use of 26-G needles. The incidence of postoperative back pain was not significantly different between the two groups.
In this case the version of the opposite parties that the anesthesia was given in sitting position is believable. After giving anaesthesia in sitting position, the patient is asked to lay on the back so that operation may be performed .So there is no truth in the complainants version that she was given anaesthesia in supine position.
The next question is about the giving of anaesthesia. It has been admitted that opposite party number 3 Dr Smt Sunita Rai/Smriti Rai isanaesthesist and she administered anaesthesia to the patient/complainant. The complainant has said that opposite party - 3 inserted needle to the patient resulting current like feeling and shock sensation in her right leg. On this the opposite party - 3 immediately took out the needle but she inserted the needle again for giving anaesthesia. Again she felt current like shock sensation in her right leg. Thereafter the opposite party - 3 instructed the medical staff of the hospital to catch hold of the complainant from both the side and thereafter she inserted the needle for the third time in the spine of the complainant and again the complainant filed same current like shock in her right leg.Here the question arises as to why should the complainant say that she has been given three pricks? Is there any enmity between the doctor and the patient? It is the patient who suffered a lot and when she has stated that at least his spine was pricked 3 times and she felt electric shock like sensation in her leg. It cannot be disbelieved only on the note of anaesthesist which was prepared later on.
We should know the benefits and risks of the spinal anaesthesia if we go through the present article .
Carl Koller, an ophthalmologist from Vienna, in 1884 first described the use of topical cocaine for analgesia of the eye. William Halsted and Richard Hall, surgeons at Roosevelt Hospital in New York City, took the idea of local anesthesia a step further by injecting cocaine into human tissues and nerves to produce anesthesia for surgery. James Leonard Corning, a neurologist in New York City, in 1885 described the use of cocaine for spinal anesthesia. Because Corning was a frequent observer at Roosevelt Hospital, the idea of using cocaine in the subarachnoid space may have come from observing Halsted and Hall performing cocaine injections. Corning first injected cocaine intrathecally into a dog and within a few minutes the dog had marked weakness in the hindquarters. Next, Corning injected cocaine into a man at the T11-T12 interspace into what he thought was the subarachnoid space. Because Corning did not notice any effect after 8 minutes, he repeated the injection.
Ten minutes after the second injection, the patient complained of sleepiness in his legs but was able to stand and walk. Because Corning made no mention of cerebrospinal fluid (CSF) efflux, most likely he inadvertently gave an epidural rather than a spinal injection to the patient.
The presence of a neuraxial fluid was first noted by Galen in AD 200, and CSF was later studied in the 1500s by Antonio Valsalva. Dural puncture was described in 1891 by Essex Wynter followed shortly by Heinrich Quincke 6 months later.
Augustus Karl Gustav Bier, a German surgeon, used cocaine intrathecally in 1898 on six patients for lower extremity surgery. In true scientific fashion, Bier decided to experiment on himself and developed a postdural puncture headache (PDPH) for his efforts. His assistant, Dr. Otto Hildebrandt, volunteered to have the procedure performed after Bier was unable to continue due to the PDPH. After injection of spinal cocaine into Hildebrandt, Bier conducted experiments on the lower half of Hildebrandt's body. Bier described needle pricks and cigar burns to the legs, incisions on the thighs, avulsion of pubic hairs, strong blows with an iron hammer to the shins, and torsion of the testicles. Hildebrandt reported minimal to no pain during the experiments; however, afterward, he suffered nausea, vomiting, PDPH, and bruising and pain in his legs. Bier attributed the PDPH to loss of CSF and felt the use of small-gauge needles would help prevent the headache.
Dudley Tait and Guido Caglieri performed the first spinal anesthetic in the United States in San Francisco in 1899. Their studies included cadavers, animals, and live patients to determine the benefits of lumbar puncture, especially in the treatment of syphilis. Tait and Caglieri injected mercuric salts and iodides into the CSF, but worsened the condition of one patient with tertiary syphilis. Rudolph Matas, a vascular surgeon in New Orleans, described the use of spinal cocaine on patients and possibly was the first to use morphine in the subarachnoid space. Matas also described the complication of death after lumbar puncture. Theodore Tuffier, a French surgeon in Paris, studied spinal anesthesia and reported on it in 1900. Tuffier felt that cocaine should not be injected until CSF was recognized.
Tuffier taught at the University of Paris at the same time that Tait was a medical student there and most likely was one of Tait's mentors. Tuffier's demonstrations in Paris helped popularize spinal anesthesia in Europe.
Arthur Barker, a professor of surgery at the University of London, reported on the advancement of spinal techniques in 1907, including the use of a hyperbaric spinal local anesthetic, emphasis on sterility, and ease of midline over paramedian dural puncture. Advancement of sterility and the investigation of decreases in blood pressure after injection helped make spinal anesthesia safer and more popular. Gaston Labat was a strong proponent of spinal anesthesia in the United States and performed early studies on the effects of Trendelenburg position on blood pressure after spinal anesthesia. George Pitkin attempted to use a hypobaric local anesthetic to control the level of spinal nerve block by mixing procaine with alcohol. Lincoln Sise, an anesthesiologist at the Lahey Clinic in Boston, used Barker's technique of hyperbaric spinal anesthesia with both procaine and tetracaine.
Spinal anesthesia became more popular as new developments occurred, including the introduction in 1946 of saddle nerve block anesthesia by Adriani and Roman-Vega. However, in 1947 the well-publicized case of Woolley and Roe (United Kingdom) resulted in two patients becoming paraplegic in one day. Across the Atlantic, reports of paraplegia in the United States similarly caused anesthesiologists to discontinue the use of spinal anesthesia. The development of novel intravenous anesthetic agents and neuromuscular blockers coincided with the decreased use of spinal anesthesia. In 1954, Dripps and Vandam described the safety of spinal anesthetics in more than 10,000 patients, and spinal anesthesia was revived.
In the field of obstetrics, over 500,000 spinals had been performed on American women by the mid-1950s. Despite spinal anesthesia being the most frequently used technique for vaginal delivery and cesarean section in the 1950s, subsequent improvements in epidural technology resulted in a decline in obstetric spinal anesthesia in the late 1960s. The Third National Audit Project (NAP3) estimated 133,525 obstetric spinals were performed in 2006 in the United Kingdom.
The early development of spinal needles paralleled the early development of spinal anesthesia. Corning chose a gold needle that had a short bevel point, flexible cannula, and set screw that fixed the needle to the depth of dural penetration. Corning also used an introducer for the needle, which was right angled. Quincke used a beveled needle that was sharp and hollow. Bier developed his own sharp needle that did not require an introducer. The needle was larger bore (15 or 17 gauge) with a long, cutting bevel. The main problems with Bier's needle were pain on insertion and the loss of local anesthetic due to the large hole in the dura after dural puncture. Barker's needle did not have an inner cannula, was made of nickel, and had a sharp, medium-length bevel with a matching stylet. Labat developed an unbreakable nickel needle that had a sharp, short-length bevel with a matching stylet. Labat believed that the short bevel minimized damage to the tissues when inserted into the back.
Herbert Greene realized that loss of CSF was a major problem in spinal anesthesia and developed a smooth-tip, smaller-gauge needle that resulted in a lower incidence of PDPH. Barnett Greene described the use of a 26-gauge spinal needle in obstetrics with a decreased incidence of PDPH. The Greene needle was popular until the introduction of the Whitacre needle. Hart and Whitacre29 used a pencil-point needle to decrease PDPH from 5%-10% to 2%. Sprotte modified the Whitacre needle and in 1987 published his trial of over 34,000 spinal anesthetics. Modifications of the Sprotte needle occurred the 1990s to produce the needle that is in use today.
Spinal anesthesia has progressed greatly since 1885. Every aspect, from improved equipment and pharmacological agents to greater understanding of physiology and anatomy, have made spinal anesthesia increasingly safer. Changing clinical knowledge has seen shifts in what is considered a contraindication to spinal anesthesia, and the evolution of novel techniques, such as the use of ultrasound, have allowed spinal anesthesia in what would once have been thought impossible situations. Nonetheless, no technique is risk-free, and every effort must be made to prevent complications. Learning how to perform spinal anesthesia is an invaluable skill that all anesthesiologists should have in their armamentarium.
THE RISKS AND BENEFITS OF SPINAL ANESTHESIA Before offering a patient spinal anesthesia, an anesthesiologist not only must be aware of the indications and contraindications of spinal anesthesia but also must be able to weigh the risks and benefits of performing the procedure. This requires a thorough understanding of the available evidence, in particular how the risk-benefit ratio compares to that of any alternative, and an ability to apply the evidence to a given clinical scenario. Thus, an informed anesthesiologist can facilitate the patient in making an informed decision.
Contraindications and Risks of Spinal Anesthesia Contraindications to Spinal Anesthesia There are absolute and relative contraindications to spinal anesthesia (see Table 1). Absolute contraindications include patient refusal; infection at the site of injection; severe, uncorrected hypovolemia; true allergy to any of the drugs; and increased intracranial pressure, except in cases of pseudo-tumor cerebri (idiopathic intracranial hypertension). High intracranial pressure increases the risk of uncal herniation when CSF is lost through the needle. Spinal anesthesia is also contraindicated when the operation is expected to take longer than the duration of the nerve block or result in blood loss such that the development of severe hypovolemia is likely.
TABLE 1. Contraindications to spinal anesthesia.
Absolute Contraindications Relative Contraindications • Patient refusal • Infection at the site of injection • Uncorrected hypovolemia • Allergy • Increased intracranial pressure • Coagulopathy • Sepsis • Fixed cardiac output states • Indeterminate neurological disease Coagulopathy, previously considered an absolute contraindication, may be considered depending on the level of derangement. Another relative contraindication of spinal anesthesia is sepsis distinct from the anatomic site of puncture (eg, chorioamnionitis or lower extremity infection). If the patient is on antibiotics and the vital signs are stable, spinal anesthesia may be considered. Spinal anesthesia is relatively contraindicated in cardiac diseases with fixed cardiac output (CO) states. Aortic stenosis, once considered to be an absolute contraindication for spinal anesthesia, does not always preclude a carefully conducted spinal anesthetic.
Indeterminate neurological disease is a relative contraindication. Multiple sclerosis and other demyelinating diseases are challenging. In vitro experiments suggest that demyelinated nerves are more susceptible to local anesthetic toxicity. However, no clinical study has convincingly demonstrated that spinal anesthesia worsens such neurologic diseases. Indeed, with the knowledge that pain, stress, fever, and fatigue exacerbate these diseases, a stress-free central neuraxial nerve block (CNB) may be preferred for surgery.
Spinal anesthesia in the immunocompromised patient also presents a challenge for the anesthesiologist and is the subject of a consensus statement. Although this consensus statement does not provide prescriptive advice for every situation, it does summarize the available evidence. Previous spinal surgery was once thought to be a contraindication. Dural puncture may be difficult, and spread of local anesthetic may be restricted by scar tissue. However, there are case reports of successful spinal anesthesia in this setting, particularly with the assistance of ultrasound. There are theoretical risks in inserting a hollow-body needle through tattoo ink. However, there are no reported complications from inserting a spinal or epidural needle through a tattoo. Stylets may decrease the likelihood of transmitting a core of tissue to the subarachnoid space, and if concerned, a small skin incision may be made prior to needle insertion. Introducers serve to prevent contamination of the CSF with small pieces of epidermis, which could lead to the formation of dermoid spinal cord tumors.
Risks of Spinal Anesthesia: Complications Complications of spinal block are often divided into major and minor complications. Reassuringly, most major complications are rare. Minor complications, however, are common and therefore should not be dismissed. Minor complications include nausea, vomiting, mild hypotension, shivering, itch, hearing impairment, and urinary retention. PDPH and failed spinal block are significant, and not uncommon, complications of spinal anesthesia. We therefore consider them as moderate complications (see Table 2). Failure of spinal anesthesia has been mentioned as between 1% and 17% and is discussed further in this chapter.
TABLE 2. Complications of spinal anesthesia.
Minor Moderate Major • Nausea and vomiting • Mild hypotension • Shivering • Itch • Transient mild hearing impairment • Urinary retention • Failed spinal • Postduralpuncture headache • Direct needle trauma • Infection (abscess, meningitis) • Vertebral canal hematoma • Spinal cord ischemia • Cauda equina syndrome • Arachnoiditis • Peripheral nerve injury • Total spinal anesthesia • Cardiovascular collapse • Death Minor Complications of Spinal Anesthesia Nausea and Vomiting Nausea and vomiting presenting after spinal anesthesia are distressing for the patient and may impede the surgeon. Incidence of intraoperative nausea and vomiting (IONV) in nonobstetric surgery can be up to 42% and may be as high as 80% in parturients.
Causes are complex and multifactorial. Causes unrelated to the spinal may include patient factors (eg, anxiety, reduced lower esophageal sphincter tone, increased gastric pressure, vagal hyperactivity, hormonal changes); surgical factors (exteriorization of the uterus, peritoneal traction); and other factors (eg, systemic opioids, uterotonic drugs, antibiotics, movement). Spinal anesthesia itself may cause IONV or postoperative nausea and vomiting (PONV) via a variety of mechanisms, including hypotension, intrathecal additives, inadequate nerve block, or high nerve block. Risks factors for IONV under spinal include peak nerve block height greater than T6, baseline heart rate (HR) 60 beats/minute or more, a history of motion sickness, and previous hypotension after spinal nerve block.
Hypotension must be the first consideration when a patient complains of nausea, especially immediately after onset of spinal anesthesia. This has been long known. Evans, in his 1929 textbook on spinal anesthesia, noted that "the sudden fall in blood pressure is followed by nausea." Mechanisms and management of hypotension are covered in greater detail elsewhere (see section on cardiovascular effects of spinal anesthesia).
A variety of intrathecal additives have been shown to increase IONV or PONV. Intrathecal morphine, diamorphine, clonidine, and neostigmine all increase nausea and vomiting. Intrathecal fentanyl, however, reduces IONV, perhaps by improving nerve block quality, decreasing supplemental opioids, or decreasing hypotension.
While low spinal nerve block can cause nausea from surgical stimulation, high sympathetic spinal nerve block (with relative parasympathetic overactivity) can also result in nausea. Glycopyrrolate was shown to be better than placebo in reducing nausea during cesarean section, although the rate of nausea was still high (42%). However, prophylactic glycopyrrolate can increase hypotension after spinal anesthesia.
A recent meta-analysis suggested metoclopramide (10 mg) was effective and safe for prevention of IONV and PONV in the setting of cesarean delivery under neuraxial nerve block.
Another meta-analysis showed the serotonin 5-HT3 receptor antagonists reduced the incidence of nausea and vomiting and the need for postoperative rescue antiemetic when intrathecal morphine was used for cesarean section.
Despite some studies showing a benefit of P6 (pericardium 6 nei guan point) stimulation, based on Chinese acupuncture, a 2008 systematic review found inconsistent results in preventing IONV and PONV.
Hypotension Mechanisms and management of hypotension are covered elsewhere (see section on cardiovascular effects of spinal anesthesia).
Shivering Crowley et al reviewed shivering and neuraxial anesthesia. Spinal and epidural anesthesia, and indeed general anesthesia, may induce shivering. The incidence of shivering secondary to neuraxial nerve block is difficult to assess given the heterogeneity of studies but is about 55%. In the first 30 minutes after nerve block, spinal anesthesia decreases core body temperature faster than epidural anesthesia. After 30 minutes, both techniques cause temperature to fall at the same rate. Despite this, shivering after spinal anesthesia is no greater than after epidural anesthesia. Indeed, the intensity of shivering seems to be higher with epidurals. Postulated mechanisms for this include an inability to shiver due to more pronounced motor block with spinal anesthesia and a decreased shivering threshold with more dermatomes (and thus thermoregulatory afferents) blocked during spinal anesthesia. Several strategies have been suggested to reduce neuraxial shivering (see Table 3).
TABLE 3. Suggested strategies to prevent and treat neuraxial anesthesia shivering.
Prevention Treatment • Prewarm with forced air warmer for 15 minutes • Avoid cold epidural or intravenous fluids • Intrathecal fentanyl 20 μg • Intrathecal meperidine 0.2 mg/kg or 10 mg • Intravenous ondansetron 8 mg • Epidural fentanyl • Epidural meperidine • Intravenous meperidine 50 mg • Intravenous tramadol 0.25 mg/kg or 0.5 mg/kg or 1 mg/kg • Intravenous clonidine 30, 60, 90, or 150 μg Itch Pruritis is a well-known side effect of opiates and is more common with administration via the spinal route (46%) compared with epidural (8.5%) and systemic routes. The severity of pruritis is proportional to intrathecal morphine dose but not epidural morphine dose. Pruritis associated with neuraxial opioids is often distributed around the nose and face. Although symptoms may not be mediated via opioid receptors, pruritis can be treated with the opioid receptor antagonist naloxone.
There are reports of ondansetron being used for opioid-induced pruritis, suggesting a role of serotonin receptors in morphine-induced pruritis. A 2009 meta-analysis of obstetric patients who had received intrathecal morphine showed that 5-HT3 receptor antagonists did not reduce the incidence of pruritis but did reduce the severity of itching and the need to treat pruritis. The 5-HT3 receptor antagonists were useful in treating established pruritis (number needed to treat [NNT] = 3).
Hearing Impairment Hearing loss, particularly in the low-frequency range, has been reported after spinal anesthesia. Quoted incidences vary widely (3%-92%). Otoacoustic emissions, an objective measurement of hearing that reflects outer hair cell function, demonstrated hearing loss to be more common than suspected, but transient, with full recovery occurring in 15 days. Other authors have similarly concluded that hearing loss commonly disappears spontaneously. A comparison of hearing loss after general and spinal anesthesia concluded that hearing loss occurs irrespective of technique. Hearing loss may or may not be associated with PDPH and may improve with an epidural blood patch. Hearing loss after spinal nerve block may be related to needle gauge and may be less common in the obstetric population. Finegold showed that hearing loss did not occur in women having elective cesarean sections when 24-gauge Sprotte needles or 25-gauge Quincke needles were used. It has been suggested that consent for spinal anesthesia should include a discussion for medicolegal reasons of possible hearing loss.
Postoperative Urinary Retention Micturition is the product of a complex interplay of physiology. Postoperative urinary retention (POUR), therefore, is often multifactorial in origin. Patient risk factors for POUR include male sex and previous urologic dysfunction. Surgical risk factors include pelvic or prolonged surgery. Anesthetic factors include anticholinergic drugs, opioids, and fluid administration (>1000 mL). POUR can occur with both neuraxial and general anesthesia.
Occurrence of POUR after neuraxial nerve block is due to neural interruption of the micturition reflex as well as bladder overdistention. Neuraxial opioids exert an effect at the spinal cord and the pontine micturition center. The parasympathetic block induced by spinal anesthesia must end before voiding occurs. This usually corresponds with return of the S2-S4 segments. The type and dose of local anesthetic, as well as the use of neuraxial opioid, influence the return of spontaneous micturition. Time to micturition is quickest with 2-chloroprocaine and slowest with bupivacaine.
A recent systematic review found six studies that compared the effect of neuraxial anesthesia with other techniques. Four studies compared local infiltration with intrathecal anesthesia; three of these found lower incidences of urinary retention with local infiltration. The other two studies found no difference in time to micturition when intrathecal anesthesia was compared with general anesthesia in the first instance and general anesthesia and peripheral nerve block in the second instance.
Postdural Puncture Headache Postdural puncture headache, often classified as a minor (or at least not a major) complication, can be severe and debilitating and has been considered the neurological complication of spinal anesthesia. It is a common cause for medicolegal claims. The incidence of PDPH is influenced by patient demographics and is less common in elderly patients. In a high-risk group, such as obstetric patients, the risk after lumbar puncture with a Whitacre 27-gauge needle is about 1.7%. Needle size and type influence PDPH rate. Other risk factors include lesser body mass index (BMI), female gender, history of recurrent headaches, and previous PDPH.
Postdural puncture headache should be thought of as neither a common "minor" complication nor a rare "major" complication, but as a not uncommon "moderate" complication.
The reader is referred to Postdural Puncture Headache for further detailed information.
Major Complications of Spinal Anesthesia Major complications of spinal anesthesia include direct needle trauma, infection (meningitis or abscess formation), vertebral canal hematoma, spinal cord ischemia, cauda equina syndrome (CES), arachnoiditis, and peripheral nerve injury. The end result of these complications may be permanent neurologic disability. Other major complications include total spinal anesthesia (TSA), cardiovascular collapse, and death.
Direct Needle Trauma Neurologic injury can occur after needle introduction into the spinal cord or nerves. Although the elicitation of paresthesias during spinal anesthesia has been implicated as a risk factor for persistent neurologic injury, it is not known whether an intervention after paresthesia can prevent development of neurologic complications. A retrospective analysis found 298 of 4767 (6.3%) patients experienced paresthesia during spinal needle insertion. Of the 298, four patients had persistent paresthesia postoperatively. A further two patients with postoperative paresthesia did not have paresthesia during needle insertion. All six patients had resolution of symptoms by 24 months. When paresthesia occurs, the spinal needle may be adjacent to or penetrating neural tissue; if the latter is the case, injection of local anesthetic into the spinal nerve may result in permanent neurologic damage. Analogous controversies exist with peripheral nerve block; the implications of paresthesia techniques and extraneural and intraneural injection are the subject of much debate.
Meningitis Meningitis, either bacterial or aseptic, can occur after spinal anesthesia is performed. Sources of infection include contaminated spinal trays and medication, oral flora of the anesthesiologist, and patient infection. Most cases of meningitis after spinal anesthesia in the first half of the 20th century were aseptic and could be traced to chemical contamination and detergents.
Marinac showed that causes of drug- and chemical-induced meningitis include nonsteroidal anti-inflammatory drugs, certain antibiotics, radiographic agents, and muromonab-CD3. There also appears to be an association between the occurrence of the hypersensitivity-type reactions and underlying collagen, vascular, or rheumatologic disease. Carp and Bailey performed lumbar puncture in bacteremic rats, and only those with a circulating Escherichia coli count greater than 50 CFU/mL at the time of lumbar puncture developed meningitis. Although meningitis after lumbar puncture has also been described in bacteremic children, the incidence of meningitis after diagnostic lumbar puncture is not significantly different in bacteremic patients compared with spontaneous incidence of meningitis. Oral flora can contaminate the CSF when a spinal anesthetic is being performed, underlying the importance of wearing a mask. Streptococcus salivarius, Streptococcus viridans, Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter, and Mycobacterium tuberculosis have all been isolated in cases of bacterial meningitis after spinal anesthesia or lumbar puncture.
Vertebral Canal Hematoma Vertebral canal hematoma formation is a rare but devastating complication after spinal anesthesia. Although most spinal hematomata occur in the epidural space due to the prominent epidural venous plexus, a few reports have mentioned subarachnoid bleeding as the cause of neurologic deficits. The source of the bleeding can be from either an injured artery or an injured vein. Spinal hematoma and spinal cord ischemia have a poorer prognosis than infective complications. If new or progressive neurologic symptoms develop, an immediate neurosurgery consultation should be obtained, and magnetic resonance imaging (MRI) of the spine should be performed as soon as possible.
Spinal Cord Ischemia The superficial arterial system of the spinal cord consists of three longitudinal arteries (the anterior spinal artery and two posterior spinal arteries) and a pial plexus.
The posterior cord is relatively protected from ischemia by abundant anastomoses. The central area of the anterior spinal cord is reliant on the anterior spinal artery and therefore more prone to ischemia. Proposed mechanisms for spinal cord ischemia secondary to spinal block include prolonged hypotension, the addition of vasoconstrictors to local anesthetics, and compression of arterial supply by vertebral canal hematoma.
Cauda Equina Syndrome Cauda equina syndrome (CES) has been reported with the use of continuous spinal microcatheters. The use of hyperbaric 5% lidocaine for spinal anesthesia is associated with an increased incidence of CES, although other local anesthetics have been implicated.
Other risk factors for CES include lithotomy position, repeated dosing of local anesthetic solution through continuous spinal catheters, and possibly multiple single-injection spinal anesthetics.
Suggestions for prevention of CES from spinal anesthesia include aspiration of CSF before and after local anesthetic injection. Some suggest that when CSF cannot be aspirated after half the dose is injected, a full dose not be administered.
Limiting the amount of local anesthetic given in the subarachnoid space may help prevent CES.
Arachnoiditis Arachnoiditis can occur after spinal injection of local anesthetic solution but is also known to occur after intrathecal steroid injection. Causes of arachnoiditis include infection; myelograms from oil-based dyes; blood in the intrathecal space; neuroirritant, neurotoxic, or neurolytic substances; surgical interventions in the spine; intrathecal corticosteroids; and trauma. Arachnoiditis has been reported after traumatic dural puncture and after unintentional intrathecal injection of local anesthetics, detergents, antiseptics, or other substances.
Peripheral Nerve Injury Spinal anesthesia may indirectly result in peripheral nerve injury. The sensory nerve block induced by spinal anesthesia temporarily abolishes normal protective reflexes. Therefore, care must be taken with appropriate positioning, avoidance of tight plaster casts, and observation of distal circulation. Hence, it is imperative that there is good nursing care of limbs rendered insensate by spinal anesthesia.
Total Spinal Anesthesia Total spinal anesthesia (TSA) results in respiratory depression, cardiovascular compromise, and loss of consciousness. This may or may not be preceded by numbness, paresthesia, or weakness of the upper limb; shortness of breath; nausea; or anxiety. The mechanism of TSA is unclear.
The importance of providing cardiorespiratory support and anxiolysis is illustrated by the management of intentional TSA. Total spinal anesthesia has been used therapeutically for intractable pain. After injection of 20 mL of 1.5% lidocaine at the L3-L4 level, patients were tilted head down. Thiopental was given to prevent unpleasant sensations. After loss of consciousness, paralysis (without muscle relaxant), and pupil dilation, a laryngeal mask airway (LMA) was inserted and positive pressure ventilation applied. Ephedrine and atropine were used for cardiovascular support if required. Mechanical ventilation was required for about an hour, after which the LMA was removed.
Cardiovascular Collapse Cardiovascular collapse can occur after spinal anesthesia, although it is a rare event. Auroy and coworkers reported 9 cardiac arrests in 35,439 spinal anesthetics performed. Refer to the section on Cardiovascular Effects of Spinal Anesthesia.
Estimating the Risks of the Major Complications of Spinal Anesthesia While minor risks are often thought of as side effects, major complications are of more concern to clinicians and patients. Perception of risk can be influenced by sensational case reports, such as given by Woolley and Roe. Early efforts to assess risk were hampered by lack of good numerator (number of complications) and denominator (number of spinal nerve blocks) data. Vandam and Dripps, in an attempt to redress "unsubstantiated clinical impressions" of mid-20th century anesthesiologists, examined the records of over 10,000 spinal anesthetics. They concluded that objections to spinal anesthesia were undeserved. Retrospective evidence from Finland for the period 1987-1993 estimated the risk of major complication following spinal anesthesia at 1 in 22,000. A no-fault compensation scheme was thought to increase data veracity. Swedish data (Moen) from the period 1990-1999 found a similar risk of 1 in 20,000-30,000. Although good evidence at the time, the Scandinavian evidence was criticized because of retrospective design, which risks underreporting. Moreover, numerator data sourced from administrative databases may not indicate either causation or final outcome.
Auroy attempted to address weaknesses of an earlier study by setting up a telephone hotline, allowing contemporaneous assessment of causality. This prospective study from 1998 to 1999 investigated complications from any type of regional anesthesia. Auroy's results relied on voluntary contribution by French anesthesiologists (<6% participation rate) and may have been skewed by differing complication rates in those willing to participate. A 2007 review found a much higher incidence of neurological complications after spinal anesthesia in Auroy's work (3.7-11.8 per 10,000) compared with Moen's work (0.4 per 10,000). Auroy, unlike Moen, included peripheral neuropathy and radiculopathy in the numerator data.
Designing a prospective study to accurately quantify the risk of spinal anesthesia has been difficult due to the low incidence of major complications. The NAP3 of the Royal College of Anaesthetists is the best evidence to date on major complications after CNB. NAP3 is notable for a variety of reasons: It is the largest prospective audit of CNB to date; it achieved a 100% return rate; and it gathered numerator and denominator data from a variety of sources. It also investigated causality and outcome.
Numerator data in NAP3 pertained to major complications over a 12-month period (2006-2007). Reports came from local hospital reporters and clinicians. Litigation authorities, medical defense organizations, journals, and even Google searches of media reports were reviewed to identify missed complications. Complications were classified as infections, hematomata, nerve injuries, cardiovascular collapses, and wrong-route errors. Notably, PDPH was not included as a major complication. Complications were examined by a panel, and the likelihood of CNB as the cause was established. Denominator data were sourced from a 2-week census and validated by contacting a number of organizations and databases.
The findings of permanent harm were presented optimistically or pessimistically (see Table 4). Optimistic figures excluded complications where recovery was likely or causality tenuous.
TABLE 4. Useful numbers for quoting risk to patients.
Central Neuraxial block Risk (Pessimistic) Risk (Optimistic) Permanent harm from major complication 1 in 25,000 1 in 50,000 Death and paraplegia 1 in 50,000 1 in 150,000 Permanent harm after any type of CNB was pessimistically 1:23,500 and optimistically 1:50,500. The risk of death or paraplegia after any type of CNB was pessimistically 1:54,500 and optimistically 1:141,500. The incidences of complications of spinals and caudals were at least half that of epidurals and combined spinal-epidural (CSE) nerve blocks. Of approximately 700,000 CNBs, 46% were spinals. Although the authors cautioned against subgroup analysis, the obstetric setting was found to have a low incidence of complications, while the adult perioperative setting had the highest complications. Complete or nearcomplete neurological recovery occurred in 61% of cases.
Importantly, NAP3 did not examine minor complications or major complications without permanent harm. For example, patients may have had cardiovascular collapse requiring intensive care or have had meningitis, but as they made a full recovery were excluded from even the pessimistic calculation. These are complications a patient would consider severe. The authors did acknowledge their figures represent a minimum possible incidence of complications; however, others have speculated that they may have overestimated risk. As there was no control group, NAP3 cannot answer if CNB is safer than other techniques such as general anesthesia.
The NAP3 study reassured us that permanent harm as a result of spinal anesthesia is rare. The large scope and excellent methodology of NAP3 mean a similar audit is unlikely to be repeated soon. Efforts should be made in ameliorating "minor" and "moderate" complications that are more likely to trouble our patients. In particular, PDPH deserves special attention.
Major complications, nonetheless, do happen, and every effort must be made to prevent them. Awareness of the low risk of serious complications should not give rise to complacency.
Indeed, a given complication may become so rare that a single anesthesiologist is unlikely to encounter it in a lifetime of practice. However, given the catastrophic nature of such complications, ongoing vigilance is of paramount importance.
Previous Indications and Benefits of Spinal Anesthesia Indications Spinal anesthesia provides excellent operating conditions for surgery below the umbilicus. Thus, it has been used in the fields of urological, gynecological, obstetric, and lower abdominal and perineal general surgery. Likewise, it has been used in lower limb vascular and orthopedic surgery. More recently, spinal anesthesia has been used in surgery above the umbilicus (see section on laparoscopic surgery).
Benefits of Spinal Anesthesia Although spinal anesthesia is a commonly used technique, with an estimated 324,950 spinal anesthetics each year in the United Kingdom alone, mortality and morbidity benefits are difficult to prove or disprove. It was hypothesized that due to beneficial modulation of the stress response, regional anesthesia would be safer than general anesthesia. However, clinical trials have been contradictory, and debates continue over the superiority of one technique over the other. Evaluations of the benefits of spinal block are troubled by the heterogeneity of studies and arguments about whether analysis should include intention to treat. In addition, much of the evidence for the benefits of neuraxial block pertains to epidurals, and some reviews do not differentiate between spinal and epidural anesthesia. For example, CNB has been shown to reduce blood loss and thromboembolic events. However, the authors of these studies were wise not to analyze spinal and epidural anesthesia individually, as the subgroup sample size would have been inadequate. Further studies are required to elucidate the relative benefits of each technique.
An obvious benefit of spinal anesthesia is the avoidance of the many risks of general anesthesia. However, it must be remembered that there is always the possibility of conversion to general anesthesia, and an emergent general anesthesia may be riskier than a planned general anesthesia.
Spinal anesthesia is advantageous in certain clinical settings. It is now commonplace for women having cesarean delivery to have a neuraxial nerve block. Spinal anesthesia avoids the problems associated with general anesthesia in the pregnant patient, notably risks of difficult airway, awareness, and aspiration. Refer to Obstetric Regional Anesthesia.
Maternal blood loss has been found to be lower with spinal compared with general anesthesia. Falling maternal mortality rates have been attributed to the increase in the practice of regional anesthesia. Moreover, regional anesthesia allows a mother to be awake for childbirth and a partner to be present if desired. However, a Cochrane review found no evidence of the superiority of regional anesthesia over general anesthesia with regard to major maternal or neonatal outcomes Likewise, a 2005 meta-analysis showed cord pH, an indicator of fetal well-being, to be lower with spinal compared with epidural and general anesthesia, although this may have been due to the use of ephedrine in the studies analyzed.
Nonetheless, spinal anesthesia remains the technique of choice for many obstetric anesthesiologists because of safety, reliability, and patient expectation.
A 2005 review of "best practice" for hip fractures found spinal anesthesia to have consistent benefits, and recommended the use of regional anesthesia "whenever possible." Benefits cited included reduced mortality, deep vein thrombosis (DVT), transfusion requirements, and pulmonary complications. However, these recommendations, based on two reviews, illustrate the shortcomings of the available evidence. The first review had a heterogeneous population and limited power for subgroup analysis; extrapolating the findings to spinal anesthesia for hip fracture surgery is therefore questionable. The second review found only a borderline difference in mortality at 1 month and no difference at 3 months. Moreover, all included studies had methodological flaws.
The stress response to cardiac surgery is reduced by intrathecal bupivacaine in combination with general anesthesia122 and partially attenuated by intrathecal morphine. Low-dose intrathecal morphine (259 ± 53 μg) has been shown to facilitate early extubation after cardiac surgery. A meta analysis of intrathecal morphine in cardiac surgery showed a modest decrease in morphine use and pain scores, although earlier extubation was only seen in a subset of patients receiving less than 500 μg of intrathecal morphine.
As modern anesthesia and perioperative care become safer, it will become increasingly more difficult to prove an advantage of one technique over another. The ideal technique may in fact be a permutation of general anesthesia, neuraxial nerve block, peripheral nerve block, or local infiltration analgesia.
Spinal Anesthesia: The Final Risk-Benefit Analysis Once armed with the evidence regarding the risks and benefits of spinal anesthesia, the anesthesiologist must decide whether the evidence applies to the individual patient and clinical situation. Although complications can be devastating, NAP3 reassured us that major complications from spinal anesthesia are rare. Compelling benefits are harder to prove, yet there are advantages in certain clinical situations. Furthermore, the risk-benefit ratio must be compared with the risk-benefit ratio of available alternatives. The historical rise in safety of spinal anesthesia has been paralleled by a rise in safety of alternative techniques, including epidural anesthesia, peripheral nerve block, local infiltration analgesia, and of course general anesthesia. This competition between alternate techniques is likely to continue. Moreover, different modalities can be used in conjunction, complicating the final decision. The modern anesthesiologist must consider this matrix of risk-benefit ratios, which is beyond the scope of this chapter.
In the present case the opposite party - 3 has admitted that she pricked the spinal twice for administering anaesthesia but the complainant has specifically mentioned in her complaint that she has been pricked thrice for giving anaesthesia. A common rule in the field of anaesthesia is that, if you prick the spinal first time and the patient suffers an electric shock then it must be aborted. In this case the opposite party - 3 did not about the procedure but she continued the process even after first failure. In normal course we see so many cases of spinal anaesthesia but such peculiar circumstances rarely comes to our knowledge. The size of needle, the dose of anaesthesia and the response, are very important for an anaesthesist to administer anaesthesia. The opposite parties counsel drew our attention towards the report of SGPGI which was called by this court. Department of anaesthesiology,SGPGI in his report dated 17.12.2018 has stated that all the experts were of the opinion that there seems no issues as regards to technique of anaesthesia, drugs administered and the experience of anaesthesiologists in this particular case. Further the incidence of neurological complication after spinal anaesthesia is 1/10,000 whereas the incidence of severe neurological complication following spinal anaesthesia is reported to be 0.5/10,000 patients. The opposite parties insisted that this expert opinion of SGPGI did not find any negligence on the part of the treating doctor. But in this report nothing has been said as to how many times the anaesthetic NEEDLE can be pricked if first prick fails ? Nothing has been said about the puncturing of spinal nerve during the spinal anaesthesia. So this report clearly shows that this in complete report has been forwarded to support the opposite parties. There is no reason shown in this report about the current like sensation filed by the complainant in her right leg. What was the need of giving repeated insertion of anaesthetic needle when first time the result was hopeless. We all know that if any nerve is touched or pricked the direct effect will be on that part where this nerve travels. The sciatic nerve is the longest, largest nerve in your body. Your sciatic nerve roots start in your lower back and run down the back of each leg. Sciatica is the pain or discomfort if your sciatic nerve gets compressed or pinched. People who are pregnant, have a sedentary lifestyle or have diabetes have a higher risk of sciatica. Except sciatic nerve , there are other nerve which travel to the lower limb. By the help of figure by the help of this figure we can see the new system going towards both of the Lacs from lumber region.
Now we come to see the admission letter/consent form available in the record. It is a printed form having the signature of MrJagdishwar Singh, husband of the complainant. In one para 2 (Ga) it has been written that the condition of my patient is that, that the surgeon is refusing to operate but I asked him to give one opportunity keeping trust on the God and I am ready for every consequences before and after operation. The consent form is most important document before performing any operation or before giving anaesthesia to any person. On this consent form there is no signature of any Dr or any person on behalf of the opposite parties. It is a general consent form but it has not been mentioned as to which serious consequences may happen in giving anaesthesia or during operation.
Consent and the Indian medical practitioner Consent is a legal requirement of medical practice and not a procedural formality. Getting a mere signature on a form is no consent. If a patient is rushed into signing consent, without giving sufficient information, the consent may be invalid, despite the signature. Often medical professionals either ignore or are ignorant of the requirements of a valid consent and its legal implications. Instances where either consent was not taken or when an invalid consent was obtained have been a subject matter of judicial scrutiny in several medical malpractice cases. This article highlights the essential principles of consent and the Indian law related to it along with some citations, so that medical practitioners are not only able to safeguard themselves against litigations and unnecessary harassment but can act rightfully.
INTRODUCTION Legally, two or more persons are said to consent when they agree upon the same thing in the same sense.[1] Consent must be obtained prior to conducting any medical procedure on a patient. It may be expressed or implied by patient's demeanour. A patient who comes to a doctor for treatment implies that he is agreeable to general physical (not intimate) examination.[2] Express consent (verbal/written) is specifically stated by the patient. Express verbal consent may be obtained for relatively minor examinations or procedures, in the presence of a witness.[3] Express written consent must be obtained for all major diagnostic, anaesthesia and surgical procedures as it is the most undisputable form of consent.
ESSENTIAL PRINCIPLES OF A VALID CONSENT AND THE INDIAN LAW A doctor must take the consent of the patient before commencing a treatment/procedure except in emergencies, informed consent should be obtained sometime prior to the procedure so that the patient does not feel pressurised or rushed to sign. On the day of surgery, the patient may be under extreme mental stress or under influence of pre-medicant drugs which may hamper his decision-making ability. Consent remains valid for an indefinite period, provided there is no change in patient condition or proposed intervention.[4] It should be confirmed at the time of surgery.[4] Consent must be taken from the patient himself.
The doctor before performing any procedure must obtain patient's consent.[5] No one can consent on behalf of a competent adult. In Dr. Ramcharan Thiagarajan Facs versus Medical Council of India case,[6] disciplinary action was awarded to the surgeon for not taking a proper informed consent for the entire procedure of kidney and pancreas transplant surgery from the patient. In some situations, beside patient consent, it is desirable to take additional consent of spouse. In sterilisation procedures, according to the Ministry of Health and Family Welfare, Government of India guidelines, consent of spouse is not required.[7] The Medical Council of India (clause 7.16) however states that in case an operation carries the risk of sterility, the consent of both husband and wife is needed.[8] It is advisable to take consent of spouse when the treatment or procedure may adversely affect or limit sex functions, or result in death of an unborn child.[9] In case of minor, consent of person with parental responsibility should be taken.[10] In an emergency, the person in charge of the child at that time can consent in absence of parents or guardians (loco parentis).[11] In a medical emergency, life-saving treatment can be given even in absence of consent.
Refusing treatment in life-threatening situations due to non-availability of consent may hold the doctor guilty, unless there is a documented refusal to treatment by the patient. In Dr. TT Thomas versus Smt. Elisa and Orscase,[12] the doctor was held guilty of negligence for not operating on a patient with life-threatening emergency condition, as there was no documented refusal to treatment.
The patient should have the capacity and competence to consent.
A person is competent to contract[13] if (i) he has attained the age of majority,[14] (ii) is of sound mind[15] and (iii) is not disqualified from contracting by any law to which he is subject. The legal age for giving a valid consent in India is 18 years.[14] A child >12 years can give a valid consent for physical/medical examination (Indian Penal Code, section 89).[3] Prior to performing any procedure on a child <18 years, it is advisable to take consent of a person with parental responsibility so that its validity is not questioned. If patient is incompetent, then consent can be taken from a surrogate/proxy decision maker who is the next of kin (spouse/adult child/parent/sibling/lawful guardian).[11] Consent should be free and voluntary.
Consent is said to be free[16] when it is not caused by coercion,[17] undue influence,[18] fraud,[19] misrepresentation,[20] or mistake.[21,22,23] Consent should be informed.
Consent should be on the basis of adequate information concerning the nature of the treatment procedure.[5] Consent should be informed and based on intelligent understanding. The doctor must disclose information regarding patient condition, prognosis, treatment benefits, adverse effects, available alternatives, risk of refusing treatment and the approximate treatment cost. He should encourage questions and answer all queries.[2] If the possibility of a risk, including the risk of death, due to performance of a procedure or its refusal is remote or only theoretical, it need not be explained.[5] Exceptions to physician's duty to disclose include[24] : (i) Patient refusal to be informed; this should be documented. (ii) If the doctor feels that providing information to a patient who is anxious or disturbed would not be processed rationally by him and is likely to psychologically harm him, the information may be withheld from him (therapeutic privilege); he should then communicate with patient's close relative, family doctor or both.
The "adequate information" must be furnished by the doctor (or a member of his team) who treats the patient.[5] Information imparted should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not.[5] Consent should be procedure specific.
Consent given only for a diagnostic procedure, cannot be considered as consent for the therapeutic treatment.[5] Consent given for a specific treatment procedure will not be valid for conducting some other procedure.[5] In Samira Kohli versus Dr. Prabha Manchanda and Anr case,[5] the doctor was held negligent for performing an additional procedure on the patient without taking her prior consent. An additional procedure may be performed without consent only if it is necessary to save the life or preserve the health of the patient and it would be unreasonable to delay, until patient regains consciousness and takes a decision.[5] A common consent for diagnostic and operative procedures may be taken where they are contemplated.[5] Consent obtained during the course of surgery is not acceptable.
In Dr. Janaki S. Kumar and Anr. versus Mrs. Sarafunnisa case, [25] in an allegation of performing sterilisation without consent, it was contended that consent was obtained during the course of surgery. The commission held that the patient under anaesthesia could neither understand the risk involved nor could she give a valid consent.
Consent for blood transfusion.
When blood transfusion is anticipated, a specific written consent should be taken,[24] exception being an emergency situation where blood transfusion is needed to save life and consent cannot be attempted.[26] In M. Chinnaiyan versus Sri. Gokulam Hospital and Anrcase,[27] court awarded compensation as patient was transfused blood in the absence of specific consent for blood transfusion.
Consent for examining or observing a patient for educational purpose Prior to examining or observing patients for educational purpose, their consent must be taken.[28] Blanket consent is not valid.
Consent should be procedure specific. An all-encompassing consent to the effect 'I authorize so and so to carry out any test/procedure/surgery in the course of my treatment' is not valid.[29] Fresh consent should be taken for a repeat procedure.
A fresh written informed consent must be obtained prior to every surgical procedure that includes re-exploration procedure. In Dr. Shailesh Shah versus AphraimJayanand Rathod case,[30] the surgeon was found deficient in service and was liable for compensation as he had performed a re-exploration surgery without a written consent from the patient.
Surgical consent is not sufficient to cover anaesthesia care.
The surgeons are incapable to discuss the risks associated with anaesthesia. Informed consent for anaesthesia must be taken by the anaesthesia provider as only he can impart anaesthesia related necessary information and explain the risks involved. It may be documented by the anaesthesiologist on the surgical consent form by a handwritten note, or on a separate anaesthesia consent form.[31] Patient has the right to refuse treatment.
Competent patients have the legal and moral right to refuse treatment, even in life-threatening emergency situations.[31] In such cases informed refusal must be obtained and documented, over the patient's witnessed signature.[32] It may be advisable that two doctors document the reason for non-performance of life-saving surgery or treatment as express refusal by the patient or the authorised representative and inform the hospital administrator about the same.
To detain an adult patient against his will in a hospital is unlawful.[9] If a patient demands discharge from hospital against medical advice, this should be recorded, and his signature obtained.[9] Unilaterally executed consents are void.
Consent signed only by the patient and not by the doctor is not valid.[33] Witnessed consents are legally more dependable.
The role of a witness is even more important in instances when the patient is illiterate, and one needs to take his/her thumb impression.[34] Consent should be properly documented Video-recording of the informed consent process may also be done but with a prior consent for the same. This should be documented. It is commonly done for organ transplant procedures. If consent form is not signed by the patient or is amended without his signed authorisation, it can be claimed that the procedure was not consented to.[10] Patient is free to withdraw his consent anytime.
When consent is withdrawn during the performance of a procedure, the procedure should be stopped. The doctor may address to patient's concerns and may continue the treatment only if the patient agrees. If stopping a procedure at that point puts patient's life in danger, the doctor may continue with the procedure till such a risk no longer exists.[10] Consent for illegal procedures is invalid.
There can be no valid consent for operations or procedures which are illegal.[24] Consent for an illegal act such as criminal abortion is invalid.[9] Consent is no defence in cases of professional negligence.[9] HOW TO OBTAIN A VALID CONSENT AND CONSENT FORMAT.
Always maintain good communication with your patient and provide adequate information to enable him make a rational decision.[35] It is preferable to take consent in patient's vernacular language. It may be better to make him write down his consent in the presence of a witness.[34] It is desirable to use short and simple sentences and non-medical terminology that is written/typed legibly.[36] Patient information sheets (PIS) depicting procedure related information, including pre-operative and post-operative pre-cautions in patient's understandable local language with pictorial representation may facilitate the informed consent process. These may help in providing consistently accurate information to the patients.[35] PIS should be handed over to the patients after explaining the contents. Even videos may be used as an aid in increasing patient understanding.[37] Though there is no standard consent format, it may include the following [e.g., Figure 1]:[38] Figure 1 Anaesthesia informed consent form Document the fact that patient and relatives were allowed to ask questions, and their queries were answered to their satisfaction.
Date and time Patient related: Name, age and signature of the patient/proxy decision maker Doctor related: Name, registration number and signature of the doctor Witness: Name and signature of witness Disease-related: Diagnosis along with co-morbidities if any Surgical procedure related: Type of surgery (elective/emergency), nature of surgery with antecedent risks and benefits, alternative treatment available, adverse consequences of refusing treatment Anaesthesia related: Type of anaesthesia (general and/or regional, local anaesthesia, sedation) including risks Blood transfusion: Requirement and related risks Special risks: Need for post-operative ventilation, intensive care, etc CONSENT IN RELATION TO PUBLICATION.
A registered medical practitioner is not permitted to publish photographs or case reports of his/her patients without their consent, in any medical or another journal in a manner by which their identity could be revealed. However, in case the identity is not disclosed, consent is not needed (clause 7.17).[8] CONSENT IN RELATION TO MEDICAL RESEARCH Consent taken from the patient for the drug trial or research should be as per the Indian Council of Medical Research guidelines[39]; otherwise it shall be construed as misconduct (clause 7.22).[8] COMMON FALLACIES IN THE CONSENT PROCESS.
The anaesthesiologist must ensure that consent is given maximum importance, and all the legal formalities are followed before agreeing to provide the services. Following are some frequent mistakes and omissions that can cost him/her dearly in the event of a mishap: Procedure is considered trivial, and consent is not taken.
Consent of relative is taken instead of the patient, even when patient is a competent adult.
Consenting person is minor, intoxicated or of unsound mind Blanket consent is taken.
Alterations or additions are made in the consent form without patient's signed authorisation.
It is not procedure specific Consent for blood transfusion is not obtained.
Fresh consent is not taken for a repeat procedure Procedure related necessary information is not given Even if the information given, it is not documented Consent lacks the signature of the treating doctor Consent is not witnessed SUMMARY It is not only ethical to impart correct and necessary information to a patient prior to conducting any medical procedure, but it is also important legally. This communication should be documented. Even professional indemnity insurance may not cover for lapses in obtaining a valid consent, considering it to be an intentional assault.
ACKNOWLEDGMENTS We gratefully acknowledge the invaluable contribution and irreplaceable advice extended to us during the preparation of this article by Mr. M Wadhwani, Advocate.
[ REFERENCES
1. Indian Contract Act, Sec 13; 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act,1872.-2386 .
2. Sharma G, Tandon V, Chandra PS. Legal sanctity of consent for surgical procedures in India. Indian J Neurosurg. 2012;1:139-43. [Google Scholar]
3. Rao NG. Textbook of Forensic Medicine and Toxicology. 2nd ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.; 2010. Ethics of medical practice; pp. 23-44. [Google Scholar]
4. Anderson OA, Wearne IM. Informed consent for elective surgery - what is best practice? J R Soc Med. 2007;100:97-100. [PMC free article] [PubMed] [Google Scholar]
5. Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No. 1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385. [Accessed on 2014 May 9]. Available from: http://www.indiankanoon.org/doc/438423/
6. Dr. Ramcharan Thiagarajan Facs vs Medical Council of India on 3 April, 2014. Karnataka High Court. Writ Petition No. 11207/2013 (GM-RES) [Accessed on 2014 July 11]. Available from: http://www.indiankanoon.com/doc/10293098/
7. Standards for Female Sterilization (1.4.4), Standards for Male Sterilization (2.4.4) Standards for Female and Male Sterilization Services. Research Studies and Standards Division, Ministry of Health and Family Welfare Government of India. 2006. Oct, [Accessed on 2014 Mar 16]. Available from: http://www.nrhmtn.gov.in/modules/Guidelines%20for%20Standard%20for%20 female%20 & %20 male%20sterilization%20services.pdf .
8. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Published in Part-III, Section 4 of the Gazette of India, dated 6th April, 2002, Amended up to December. 2010.
9. Reddy KS, Murty OP. The Essentials of Forensic Medicine and Toxicology. 32nd ed. Hyderabad: K Suguna Devi; 2013. Medical law and ethics; pp. 22-55. [Google Scholar]
10. Herring J. Medical Law and Ethics. 4th ed. United Kingdom: Oxford University Press; 2012. Consent to treatment; pp. 149-220. [Google Scholar]
11. Arora V. Role of consent in medical practice. [Accessed on 2014 Mar 21];JEvol Med Dent Sci 2013. 2:1225-9. Available from: http://www.jemds.com/data_pdf/vijay%20arora-ROLE%20OF%20CONSENT%20IN%20MEDICAL.pdf . [Google Scholar]
12. Dr. TT Thomas vs Smt Elisa and Ors on 11 August, 1986. Kerala High Court. AIR 1987 Ker 52: 1986 Ker LT 1026 (DB) [Accessed on 2014 Jun 2]. Available from: http://www.indiankanoon.org/doc/600254/
13. Indian Contract Act, Sec 11. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2384 .
14. Indian Majority Act. 1875. [Accessed on 2014 Aug 21]. Available from: http://admis.hp.nic.in/himpol/Citizen/LawLib/C0141.htm .
15. Indian Contract Act, Sec 12. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2385 .
16. The Indian Contract Act, Sec 14. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872.-2387 .
17. The Indian Contract Act, Sec 15. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2388 .
18. The Indian Contract Act, Sec 16. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5173 .
19. The Indian Contract Act, Sec 17. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2390 .
20. The Indian Contract Act, Sec 18. 1872. [Accessed on 2014 Aug 21]. Available from: http://indiankanoon.org/doc/1270593/
21. The Indian Contract Act, Sec 20. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5178 .
22. The Indian Contract Act, Sec 21. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-2395 .
23. The Indian Contract Act, Sec 22. 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act.,1872-5180 .
24. Kannan JK, Mathiharan K. Legal and ethical aspects of medical practice. In: Modi A, editor. Textbook of Medical Jurisprudence and Toxicology. 24th ed. Nagpur: Lexis Nexis Butterworths Wadhwa; 2012. pp. 61-118. [Google Scholar]
25. Dr. Janaki S Kumar and Anr vs Mrs. Sarafunnisa on 21 June, 1999. Kerala State Consumer Disputes Redressal Commission, Thiruvananthapuram. Appeal No. 850 of 1998. (1999) I CPJ 66.
26. Kekre NS. Medical law and the physician. Indian J Urol. 2008;24:135-6. [PMC free article] [PubMed] [Google Scholar]
27. M. Chinnaiyan vs. Sri. Gokulam Hospital and Anr on 25 September, 2006. III (2007) CPJ 228 NC. [Accessed on 2014 Aug 21]. Available from: http://www.indiankanoon.org/doc/1919829/
28. Doyal L. Closing the gap between professional teaching and practice. BMJ. 2001;322:685. [PMC free article] [PubMed] [Google Scholar]
29. Satyanarayana Rao KH. Informed consent: An ethical obligation or legal compulsion? J CutanAesthet Surg. 2008;1:33-5. [PMC free article] [PubMed] [Google Scholar]
30. Dr Shailesh Shah vs AphraimJayanand Rathod. National Consumer Disputes Redressal Commission New Delhi, FA No. 597 of 1995. From the order dated 8 Nov, 1995 in complaint No. 31/94, State Commission Gujarat. [Last accessed on 2014 Aug 21]. Available from: http://www.ncdrc.nic.in/fa59795.html .
31. Waisel DB. Legal aspects of anesthesia care. In: Miller RD, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 7th ed. Philadelphia USA: Churchill Livingstone Elsevier; 2010. pp. 221-33. [Google Scholar]
32. Tewari A, Garg S. Informed consent and anaesthesia. Indian J Anaesth. 2003;47:311-2. [Google Scholar]
33. Bastia BK, Kuruvilla A, Saralaya KM. Validity of consent-A review of statutes. Indian J Med Sci. 2005;59:74-8. [PubMed] [Google Scholar]
34. Bastia BK. Consent to treatment: Practice vis-à-vis principle. Indian J Med Ethics. 2008;5:113-4. [PubMed] [Google Scholar]
35. Kalantri SP. Informed consent and the anaesthesiologist. Indian J Anaesth. 2003;47:94-6. [Google Scholar]
36. Kaushik JS, Narang M, Agarwal N. Informed consent in pediatric practice. Indian Pediatr. 2010;47:1039-46. [PubMed] [Google Scholar]
37. Tompsett E, Afifi R, Tawfeek S. Can video aids increase the validity of patient consent? J ObstetGynaecol. 2012;32:680-2. [PubMed] [Google Scholar]
38. Singh D. Singh D. Informed vs. Valid consent: Legislation and responsibilities. [Accessed on 2014 Aug 21];Indian J Neurotrauma. 2008 5:105-8. Available from: http://www.medind.nic.in/icf/t08/i2/icft08i2p105.pdf . [Google Scholar]
39. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Published by: Director General Indian Council of Medical Research; 2006. [Accessed on 2014 Mar 3]. eral Ethical Issues; pp. 21-33. ] There is no separate consent form for anaesthesia. This pro forma is not in accordance with the pro forma prescribed for taking the consent. There is no separate consent to use the body for post-mortem examination for the purpose of study. There is nothing in this consent form which show that the doctor has specifically mentioned all the risks to the patient or his family members regarding operation or any other tests which may be performed. So this consent form is not a proper consent form as per the guidelines. It also shows deficiency and negligence on the part of the opposite parties.
We have seen some documents of the opposite parties the operation was performed on15.02.2014 and there is a note on the very next day regarding referenc to Dr Kaushal Agarwal for right lower limb weakness. It has also clearly written in the Department chart "weakness of right foot, unable to walk on own".
On 18.02.2014 the note says "case seen by Dr Rakesh Singh , Neurosurgeon" and it has resulted "good response in right foot - patient can put heel on ground but no response in toes." After discharged the patient was shown to manydoctors . The opposite party - 2 advised MRI on 18.02.2014 . By this MRI it is evident that damage to the spinal cord has been done. The patient was discharged on 19.02.2014 but readmitted on the very next date because there was no sensation in the right leg. The complainant received treatment till 27.02.2014 but lack of sensation continued in the right leg. When the patient was shown to Dr Kaushal Agarwal on 29.03.2014 , he observed "full right foot drop post spinal, pain in calf, tender mild". The MRI report of 01.05.2014 says "partial disk desiccation at multiple levels with no significant radiculopathy . Syrinx formation at D12 -L1 level as described above". Now here the syrinx formation came into existence.
Overview Syringomyelia cyst (syrinx) in the spinal cord Open pop-up dialog box Syringomyelia (sih-ring-go-my-E-lee-uh) is the development of a fluid-filled cyst (syrinx) within your spinal cord. Over time, the cyst can enlarge, damaging your spinal cord and causing pain, weakness and stiffness, among other symptoms.
Syringomyelia has several possible causes, though the majority of cases are associated with a condition in which brain tissue protrudes into your spinal canal (Chiari malformation).
Other causes of syringomyelia include spinal cord tumors, spinal cord injuries and damage caused by inflammation around your spinal cord.
If syringomyelia doesn't cause problems, monitoring the condition might be all that's necessary. But if you're bothered by symptoms, you might need surgery.
Symptoms Syringomyelia symptoms usually develop slowly over time. If your syringomyelia is caused by protrusion of brain tissue into your spinal canal (Chiari malformation), symptoms generally begin between ages 25 and 40.
In some cases, coughing or straining can trigger symptoms of syringomyelia, although neither causes syringomyelia.
Signs and symptoms of syringomyelia, which might affect your back, shoulders, arms or legs, can include:
Muscle weakness and wasting (atrophy) Loss of reflexes Loss of sensitivity to pain and temperature Headaches Stiffness in your back, shoulders, arms and legs Pain in your neck, arms and back Spinal curvature (scoliosis) When to see a doctor If you have any of the signs or symptoms associated with syringomyelia, see your doctor.
If you've had a spinal cord injury, watch for signs and symptoms of syringomyelia. Months to years can pass after an injury before syringomyelia develops. Make sure your doctor knows you had a spinal cord injury.
Causes It's unclear how and why syringomyelia happens. When it develops, cerebrospinal fluid -- the fluid that surrounds, cushions and protects your brain and spinal cord -- collects within the spinal cord itself, forming a fluid-filled cyst (syrinx).
Several conditions and diseases can lead to syringomyelia, including:
Chiari malformation, a condition in which brain tissue protrudes into your spinal canal Meningitis, an inflammation of the membranes surrounding your brain and spinal cord Spinal cord tumor, which can interfere with the normal circulation of cerebrospinal fluid Conditions present at birth, such as a tethered spinal cord, a condition caused when tissue attached to your spinal cord limits its movement Spinal cord injury, which can cause symptoms months or years later Complications In some people, syringomyelia can progress and lead to serious complications. Others have no symptoms.
Possible complications as a syrinx enlarges or if it damages nerves within your spinal cord include:
An abnormal curve of your spine (scoliosis) Chronic pain as a result of spinal cord damage to the spinal cord Motor difficulties, such as weakness and stiffness in your leg muscles that can affect your walking Paralysis Syringomyelia is a generic term referring to a disorder in which a cyst or cavity forms within the spinal cord. Often, syringomyelia is used as a generic term before an etiology is determined.[3] This cyst, called a syrinx, can expand and elongate over time, destroying the spinal cord. The damage may result in loss of feeling, paralysis, weakness,[4] and stiffness in the back, shoulders, and extremities. Syringomyelia may also cause a loss of the ability to feel extremes of hot or cold, especially in the hands. It may also lead to a cape-like bilateral loss of pain and temperature sensation along the upper chest and arms. The combination of symptoms varies from one patient to another depending on the location of the syrinx within the spinal cord, as well as its extent.
Syringomyelia has a prevalence estimated at 8.4 cases per 100,000 people,[5] with symptoms usually beginning in young adulthood. Signs of the disorder tend to develop slowly, although sudden onset may occur with coughing, straining, or myelopathy.
Signs and symptoms[edit] Syringomyelia causes a wide variety of neuropathic symptoms, due to damage to the spinal cord. Patients may experience severe chronic pain, abnormal sensations and loss of sensation, particularly in the hands. Some patients experience paralysis or paresis, temporarily or permanently. A syrinx may also cause disruptions in the parasympathetic and sympathetic nervous systems, leading to abnormal body temperature or sweating, bowel control issues, or other problems. If the syrinx is higher up in the spinal cord or affecting the brainstem, as in syringobulbia, vocal cord paralysis, ipsilateral tongue wasting, trigeminal nerve sensory loss, and other signs may be present.[6] Rarely, bladder stones can occur at the onset of weakness in the lower extremities.[7] Classically, syringomyelia spares the dorsal column/medial lemniscus of the spinal cord, leaving pressure, vibration, touch and proprioception intact in the upper extremities. Neuropathic arthropathy, also known as a Charcot joint, can occur, particularly in the shoulders, in patients with syringomyelia.[8] The loss of sensory fibers to the joint is theorized to lead to degeneration of the joint over time.[9] Cause[edit] Generally, there are two forms of syringomyelia: congenital and acquired. Syringomyelia is generally a chronic disorder that occurs over time, resulting in muscular atrophy. Acquired Syringomyelia can be caused by a serious physical trauma to the body such as in a road traffic accident. Syringomyelia can also be classified into communicating and noncommunicating forms. Communicating typically occurs due to lesions on the foramen magnum and noncommunicating occurring due to other spinal cord diseases.[10] Congenital[edit] The first major form relates to an abnormality of the brain called an Arnold-Chiari malformation or Chiari malformation. This is the most common cause of syringomyelia, where the anatomic abnormality, which may be due to a small posterior fossa, causes the lower part of the cerebellum to protrude from its normal location in the back of the head into the cervical or neck portion of the spinal canal. A syrinx may then develop in the cervical region of the spinal cord. Here, symptoms usually begin between the ages of 25 and 40 and may worsen with straining, called a valsalva maneuver, or any activity that causes cerebrospinal fluid pressure to fluctuate suddenly. Some patients, however, may have long periods of stability. Some patients with this form of the disorder also have hydrocephalus, in which cerebrospinal fluid accumulates in the skull, or a condition called arachnoiditis, in which a covering of the spinal cord--the arachnoid membrane--is inflamed.[11] Some cases of syringomyelia are familial, although this is rare.[12] Acquired[edit] The second major form of syringomyelia occurs as a complication of trauma, meningitis, hemorrhage, a tumor, or arachnoiditis. Here, the syrinx or cyst develops in a segment of the spinal cord damaged by one of these conditions. The syrinx then starts to expand. This is sometimes referred to as noncommunicating syringomyelia. Symptoms may appear months or even years after the initial injury, starting with pain, weakness, and sensory impairment originating at the site of trauma.[13] The primary symptom of post-traumatic syringomyelia (often referred to using the abbreviation of PTS)[14] is pain, which may spread upward from the site of injury. Symptoms, such as pain, numbness, weakness, and disruption in temperature sensation, may be limited to one side of the body. Syringomyelia can also adversely affect sweating, sexual function, and, later, bladder and bowel control. A typical cause of PTS would be a car accident or similar trauma involving a whiplash injury.[15] What can make PTS difficult to diagnose is the fact that symptoms can often first appear long after the actual cause of the syrinx occurred (e.g., a car accident occurring and then the patient first experiencing PTS symptoms such as pain, loss of sensation, and reduced ability on the skin to feel varying degrees of hot and cold a number of months after the car accident).[16] Pathogenesis[edit] The pathogenesis of syringomyelia is debated. The cerebrospinal fluid also serves to cushion the brain. Excess cerebrospinal fluid in the central canal of the spinal cord is called hydromyelia. This term refers to increased cerebrospinal fluid that is contained within the ependyma of the central canal. When fluid dissects into the surrounding white matter forming a cystic cavity or syrinx, the term syringomyelia is applied. As these conditions coexist in the majority of cases, the term syringohydromyelia is applied. The terms are used interchangeably.[17] It has been observed that obstruction of the cerebrospinal fluid spaces in the subarachnoid space can result in syrinx formation, and alleviation of the obstruction may improve symptoms. A number of pathological conditions can cause an obstruction of the normal cerebrospinal fluid spaces. These include Chiari malformation, spinal arachnoiditis, scoliosis, spinal vertebrae misalignment, spinal tumors, spina bifida, and others. The reasons that blockage of the cerebrospinal fluid space within the subarachnoid space can result in syrinx formation are not fully understood although a small posterior fossa is one known cause. It is unclear if syrinx fluid originates from bulk movement of cerebrospinal fluid into the spinal cord, from bulk transmural movement of blood fluids through the spinal vasculature into the syrinx, or from a combination of both. Recent work suggests that central nervous system compliance is the underlying problem for the central nervous system, and also that hydrocephalus and syringomyelia have related causes.[18] Diagnosis[edit] Physicians now use magnetic resonance imaging (MRI) to diagnose syringomyelia. The MRI radiographer takes images of body anatomy, such as the brain and spinal cord, in vivid detail. This test will show the syrinx in the spine or any other conditions, such as the presence of a tumor. MRI is safe, painless, and informative and has greatly improved the diagnosis of syringomyelia.[19] The physician may order additional tests to help confirm the diagnosis. One of these is called electromyography (EMG), which show possible lower motor neuron damage.[20] Note this test isn't used diagnostically for injuries to the spine but to nerves and muscles.This would be part of a patients rehab routine. In addition, computed axial tomography (CT) scans of a patient's head may reveal the presence of tumors and other abnormalities such as hydrocephalus.[21] Like MRI and CT scans, another test, called a myelogram, uses radiographs and requires a contrast medium to be injected into the subarachnoid space. Since the introduction of MRI, this test is rarely necessary to diagnose syringomyelia.[22] The possible causes are trauma, tumors, and congenital defects. It is most usually observed in the part of the spinal cord corresponding to the neck area. Symptoms are due to spinal cord damage and include pain, decreased sensation of touch, weakness, and loss of muscle tissue. The diagnosis is confirmed with a spinal CT, myelogram or MRI of the spinal cord. The cavity may be reduced by surgical decompression.[23] Furthermore, evidence also suggests that impact injuries to the thorax area highly correlate with the occurrence of a cervical-located syrinx.[24] Surgery Treating syringomyelia sometimes requires surgery. Surgery involving the spinal cord carries certain risks, and as with any medical treatment, the potential benefits have to be weighed against the possible complications. On the other hand, delaying treatment can increase the risk of permanent damage. Evaluation of the condition is necessary because syringomyelia can remain stationary for long periods of time, and in some cases progress rapidly.[25] The main goal of surgical intervention is to correct the condition which led to the formation of the syrinx. Draining the syrinx can also help, by preventing it from becoming worse, but the symptoms the syrinx has already caused may not go away.[citation needed] In cases involving an Arnold-Chiari malformation, the main goal of surgery is to provide more space for the cerebellum at the base of the skull and upper cervical spine, without entering the brain or spinal cord. This often causes the syrinx to shrink or disappear over time, as the normal flow of cerebrospinal fluid is restored. If syringomyelia is caused by a tumor, removing the tumor - if possible - is the treatment of choice.[26] Most patients' symptoms stabilize or have a modest improvement following surgery. Syringomyelia can come back, however, requiring additional surgeries which may be less effective.[27] In some cases, including both communicating and non-communicating forms of the condition, a syrinx may require ongoing drainage. This is done with a shunt, which uses tubes and valves to let cerebrospinal fluid (CSF) drain from the syrinx into another cavity within the body (usually the abdomen). This type of shunt, called a ventriculoperitoneal shunt, is particularly useful in cases involving hydrocephalus. By continually draining the syrinx, a shunt can arrest the progression of symptoms and relieve pain, headache, and tightness.[28] Many factors affect the decision to use a shunt. There are risks of injury to the spinal cord, infection, drainage becoming blocked, and bleeding, and they do not always achieve the intended results. Draining the fluid more quickly does not produce better outcomes, but for some syrinxes, a shunt is the only drainage option.[29] In the case of trauma-related syringomyelia, the surgeon operates at the level of the initial injury. The syrinx collapses at surgery, but a tube or shunt is usually necessary to prevent it from returning.[30] Non-surgical interventions[edit] Surgery is not always recommended for syringomyelia patients. While there is no medication which can cure the condition, for many patients, the main treatment is analgesia to manage the symptoms. Physicians specializing in pain management can develop a medication and treatment plan to ameliorate pain. Medications to combat any neuropathic pain symptoms such as shooting and stabbing pains (e.g. gabapentin or pregabalin) would be first-line choices. Opiates are usually prescribed for pain for management of this condition. Conversely, facet joint injections are not indicated for the treatment of syringomyelia.[31] Radiation is rare, but may be used if a tumor is involved. In these cases, it can halt the extension of a cavity and may help to alleviate pain.[32] Treatment is usually reserved for cases which are causing symptoms. Treatment may not provide enough benefits to be recommended for elderly patients, or when symptoms are stable instead of worsening. Whether treated or not, many patients are advised to avoid activities that involve straining.[33] A conservative approach may be recommended, as the natural history of syringomyelia is not yet well understood. When surgery is not currently advised, patients are monitored with regular physical evaluations and MRI's.[34] Research[edit] The precise causes of syringomyelia are still unknown, although blockage of the flow of cerebrospinal fluid has been known to be an important factor since the 1970s. Scientists in the UK and US continue to explore the mechanisms that lead to the formation of syrinxes in the spinal cord. It has been demonstrated that a block of the free flow of cerebrospinal fluid is a contributing factor in the pathogenesis of the disease. Duke University in America and Warwick University are conducting research to explore genetic features of syringomyelia.[35] Surgical techniques are also being refined by the neurosurgical research community. Successful procedures expand the area around the cerebellum and spinal cord, improving the flow of cerebrospinal fluid and thereby reducing the syrinx.[36] It is also important to understand the role of birth defects in the development of hindbrain malformations that can lead to syringomyelia, as syringomyelia is a feature of intrauterine life and is also associated with spina bifida. Learning when these defects occur during the development of the fetus can help with the understanding of this and similar disorders, and may lead to preventive treatment that can stop the formation of some birth abnormalities.[37] Diagnostic technology is another area for continued research. MRI has enabled scientists to see the situation within the spine, including syringomyelia, before any symptoms appear. A new technology, known as dynamic MRI, allows investigators to view spinal fluid flow within the syrinx. CT scans allow physicians to see abnormalities in the brain, and other diagnostic tests have also improved greatly with the availability of new, non-toxic, contrast dyes.[38] The MRI report dated 18.02.14 made the following impression "MRI features of focal increased intramedullary signal intensity in the Conus Medullaris on T2 weighted images at D12-L1 level as described above.
Early lumber spondylitis with mild anterior subluxation of L4 vertebral body with annular bulge L4/5 IV disc with attendant B/L facet joint arthrosis with Hypertrophied Ligamentum Flavum leading to thecal sac indentation with mild B/L neural foramina encroachment ."
Now we have to see what is Hypertrophied Ligamentum Flavum ?
Hypertrophy Of Ligamentum Flavum & Slip-disc Ligamentum flavum hypertrophy treatment is complex and requires specialized therapy devices and targeted therapy options by clinicians who have expertise in ligamentum flavum therapy and treatment. Chiropractic Specialty Center® (CSC) offers comprehensive non-surgical therapy options for patients with hypertrophy and buckling of ligamentum flavum.
Ligamentum flavum, a term derived from Latin meaning the yellow ligament, is a highly specialized ligament situated directly in the back or posterior aspect of the spinal canal, providing a segment-to-segment spinal connection through their laminal attachments on each side. Ligamentum flavum is a singular term, while ligamentum flava is used to describe it as a segmental ligamentum.
This article provides in-depth information on ligamentum flava, including what causes it to thicken, its function, and the best physiotherapy combined with the best chiropractic treatment options in Kuala Lumpur, Malaysia.
Symptoms Of Ligamentum Flavum Hypertrophy Ligamentum flavum thickening causes spinal canal stenosis. Spinal canal stenosis compresses the spinal cord and spinal nerve. Compressed spinal cord and spinal nerves have far-reaching consequences, including pain, numbness, tingling, weakness, paralysis, and organ failures. Hypertrophy of ligamentum flavum is seen in patients with:
Slip-discs or slipped disc (Disc bulge, herniation, extrusions, and fragmentation) Spondylolysis Spondylolisthesis Spondylolysis Sciatica Facet hypertrophy Back pain Neck pain The seven most Common symptoms of ligamentum flavum include:
Neck pain Upper back or mid back pain Low back pain Difficulty walking or standing Difficulty when standing following a period of sitting Pain, numbness, tingling, burning, or weakness in the shoulders, arms, elbows, wrists, hands, and finger Pain, numbness, tingling, burning, or weakness in the buttocks, hips, thighs, knees, legs, ankle, feet, or toes What Is The Function Of Ligamentum Flavum?
The ligamentum flava or flavum, or the yellow ligament, is a paired, thick, broad spinal ligament that runs from segment to segment connecting the spine with its attachment on the lamina (thin bony surface at the back of the spine). Ligamentum flavum is a paired ligament, with one on each side of the spine. We have listed the five critical functions of Ligamentum flavum:
Maintains an upright posture when standing Assists when changing positions from a flexed or bent position into an upright posture (helps to straighten the spine after bending or flexion) Protects the spine from excessive flexing (bending forward) or an excessive side-bending (lateral flexion) Guides spinal joint alignment and positioning when changing positions Connects spinal bones What Is Hypertrophy Of Ligamentum Flvaum Or Flava Hypertrophy means thickening or enlargement of an organ or tissue. Ligamentum flavum hypertrophy relates to thicking, enlargement. Ligamentum flavum hypertrophy is an issue because of its proximity to the spinal cord, spinal joints, and spinal nerves. A thickened or enlarged ligamentum flavum is a leading cause of spinal canal stenosis (shrinkage in the spinal canal), foraminal stenosis, and spinal joint arthritis or hypertrophy.
What Is The Normal Ligamentum Flavum Measurement On average, a normal or healthy ligamentum flavum should be about 3.5mm thick. However, for patients with smaller statures and those of Asian descent, the average standard thickness should be less than 3.5mm. Thickening progresses through life, and slight sub-millimeter thickening is expected or typical in the elderly. T What Are The Dangers Of a Thickend& Hypertrophied Ligamentum Flaum?
The danger with thickening of ligamentum flavum is spinal canal stenosis, spinal cord compression, and nerve impingements. As the ligament increases in size, it shrinks or reduces the available space for the spinal cord and spinal nerve. The moderately hypertrophied ligamentum can buckle during sitting or standing, causing severe canal stenosis. The same will also occur with a severe thickening; however, severely thicked ligaments cause severe stenosis in supine (non-weight-bearing position) as well as with weight-bearing (standing or sitting).
Moderate or severe hypertrophy of ligamentum flavum can cause excruciating pain, numbness, tingling, and weakness. Moreover, it is a leading cause of paralysis.
Buckling Of Ligamentum Flvum Buckling in reference to ligamentum flavum is a bulged, bend, curve outward, or bunch up with standing or sitting. Buckling is common in mild and moderate ligamentum flavum. Buckling of ligamentum flavum is dangerous as it can compress the spinal cord and spinal nerves. Therefore, even mild ligamentum flavum hypertrophy can be hazardous as it can buckle and impact the spinal canal, spinal cord, and spinal nerves in the same manner that moderate or severe ligamentum flavum hypertrophy causes. The moderate or mild ligamentum flavum hypertrophy buckles more because they are more elastic than the severely thickened ligament flavum.
The three most common causes of lower back pain in Malaysia are slipped disc, facet joint injury, and ligamentous issues. These three conditions co-exist most of the time, leading to severe pain in the back, buttocks, or lower limbs. It is challenging to differentiate clinically between a slipped disc, facet joint injuries, or ligamentous issues.
Facet Hypertrophy & Thickening Of Ligamentum Falvum?
Spinal joint (facet) injuries lead to facet hypertrophy or facet syndrome, a complicated spinal condition that requires urgent care. A thickened spinal joint (facet) is known as Facet hypertrophy.
Joints of the spine or facet are connected through series of ligaments. These ligaments encapsulated (fully surround) the spinal joint. Spinal joint ligaments arise from ligamentum flavum. Injuries to spinal joints or activities that cause thicking of the ligamentum flavum are interrelated issues. In other words, an injured spinal joint can damage and thicken ligamentum flavum, and a thickened ligamentum flavum may cause facet hypertrophy. As such, facet and ligamentum flavum are co-conditions that often present simultaneously.
Facet hypertrophy, Ligamentum Flavum Thickening & Slipped Discs Patients with hypertrophy of ligamentum flavum also present with facet hypertrophy and slipped disc. In other words, you can't get a thickened ligament flavum until you get a slipped disc or facet damage or hypertrophy first. The three most severe causes of neck and back pain are:
Facet Hypertrophy Ligamentum flavum thickening Slipped discs or slip-discs Slipped discs, facet, and ligamentum flavum thicking are interrelated spine conditions that occur in successive stages, one following the other. Continued or unabated progression is typical in patients who neglect or ignore mild issues. Chiropractic Specialty Center® offers the best and most advanced neck pain, back pain, and ligamentum flavum treatment options without surgery or injections; contact our main center on 03 2093 1000 now! To recover, you will need a holistic measure that targets the root causes of all issues simultaneously.
Learn more about our non-operative treatment for slipped disc through technology that others do not have in Kuala Lumpur, Malaysia:
Symptoms Of Facet hypertrophy Or Spinal Joint Injury Patients with disc damages are more likely to report pain upon forwarding bending of the trunk. Whereas patients with facet joint injuries often complain of pain with extension of the lower back. Other than that, the site of maximal tenderness can be different between disc and facet joint injuries. The most tender spot for a patient with disc damage is more centrally around the spinous process. However, the most tender spot for a facet joint injury is more towards the side of the damaged side.
Hypomobility of one or more spinal segments is commonly associated with a slipped disc and facet joint damages. This can be one of the causes that contribute to lower back pain. Intervertebral segments with restricted movement should be corrected with mobilization or manipulation of the joint to manage the lower back pain.
What Is The Best Treatment For Hypertrophy Of Ligamentum FLavum?
Ligamentum flavum treatment and recovery are possible with evidence-based clinical forms of physiotherapy combined with non-rotatory chiropractic treatments. Physiotherapy or chiropractic as a standalone method of care is insufficient for ligamentum flavum. Rotatory chiropractic treatments such as the Gonstead chiropractic technique or the Diversified procedures are dangerous for patients with ligamentum flavum hypertrophy. The best way of chiropractic treatment of a thickened ligamentum flavum is through the Activator methods of chiropractic.
However, chiropractic treatment is not enough. As such, patients will also need advanced systems of physiotherapy. Here is a list of the three most effective physiotherapy procedures for ligamentum flavum:
High-intesiy laser therp ESWT shockwave therapy Therapeutic Ultrasound Chiropractic Specialty Cetner® in Malaysia is the only center that provides comprehensive non-surgical treatments for slipped discs (spinal disc damage), joints (facet injuries), and issues relating to hypertrophy of ligamentum flavum. Our corrective teams of chiropractors and physiotherapists are the best in Malaysia. Our chiropractors and physiotherapists provide combined treatment for back and neck pain through manual or hands-on methods and therapy via breakthrough spine technology to fix and repair your spine without surgery or injections. This highly sophisticated system of care is termed NSD Therapy®. CSC is the only NSD Therapy® certified center in Asia.
What is disc desiccation?
Your spine is made up of a stack of bones called vertebrae. In between each vertebra, you have a tough, spongy disc that acts as a shock absorber. Over time, these discs wear down as part of a process called degenerative disc disease.
Disc desiccation is one of the most common features of degenerative disc disease. It refers to the dehydration of your discs. Your vertebral discs are full of fluid, which keeps them both flexible and sturdy. As you age, the discs begin to slowly lose their fluid, limiting the ability to function properly.
What are the symptoms?
The first sign of disc desiccation is usually stiffness in your back. You may also feel pain, weakness, or a tingling sensation in your back. Depending on which discs are affected, you could also feel numbness in your lower back.
In some cases, the pain or numbness will travel from your back and down one or both legs. You may also notice a change in your knee and foot reflexes.
What causes it?
Disc desiccation is usually caused by wear and tear on your spine, which happens naturally as you age.
Several other things can also cause disc desiccation, such as:
trauma from a car accident, fall, or sports injury repeated strain on your back, especially from lifting heavy objects ankylosing spondylitis How is it diagnosed?
Your doctor will likely start with a physical exam. They may ask you to do certain movements to see whether they cause any pain. This can also help your doctor figure out which discs might be affected.
Next, you'll likely need an X-ray, CT scan, or MRI scan to give your doctor a better look at your vertebrae and discs. Dehydrated discs are usually thinner and less consistent in shape. These images will also show any additional problems that might be causing your back pain, such as a ruptured or herniated disc.
How is it treated?
If your symptoms are mild, your doctor may advise you to maintain a moderate weight, practice good posture, and avoid common back pain triggers, such as lifting heavy objects.
If your symptoms are more severe, there are several treatment options that can help, including:
Medication: Pain relievers, including nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil) and naproxen (Aleve), can help reduce pain.
Massage therapy: Relaxing the muscles near the affected vertebrae can help relieve painful pressure.
Physical therapy: A physical therapist can teach you how to strengthen the core muscles that support your trunk and take pressure off your back. They can also help you improve your posture and come up with strategies to avoid movements or positions that may trigger symptoms.
Spinal injections: A corticosteroid injection may help reduce inflammation and pain in your back.
In rare cases, you may need spinal surgery. One type, called spinal fusion surgery, involves permanently joining two vertebrae. This can help to stabilize your spine and prevent movements that cause pain. Other options include disc replacement or adding another kind of spacer between your vertebrae.
Is it preventable?
Disc desiccation is a normal part of aging, but there are several things you can do to slow down the process, including:
exercising regularly and incorporating core-strengthening exercises into your routine regularly stretching maintaining a moderate weight to avoid putting extra pressure on your spine not smoking, which can speed up the degeneration of your discs staying hydrated maintaining good spinal posture Certain core exercises can also help older people improve muscle function.
Takeaway Disc desiccation may be an unavoidable part of a long, healthy life, but there are several options for managing any symptoms you have.
If you're having back pain, work with your doctor to come up with a pain management plan. This usually involves a combination of medication, physical therapy, and exercise.
So it is clear that due to defective spinal anaesthesia and lack of knowledge regarding anaesthesia resulted in the pity situation of the patient and at present as we have seen that she is 60% disable. Clearly this is the case of foot drop after administering anaesthesia . Regarding foot drop we have seen the following medical article:
Foot drop after spinal anesthesia for cesarean section: a case report Ali Dastkhosh,1 Majid Razavi,2 and MehryarTaghavi Gilani2 Author information Copyright and License information Disclaimer Abstract Objective Spinal anesthesia is the preferred anesthetic technique for cesarean section. Neurological complications are very rare and often transient after spinal anesthesia.
Case report In the present case, a 37-year-old woman was considered eligible for cesarean section due to fetal distress. She underwent spinal anesthesia with a 25-gauge pencil-point spinal needle. In the sitting position, 3 mL of 0.5% bupivacaine was injected following free flow of cerebrospinal fluid. The cesarean delivery was uneventful without severe and significant hemodynamic changes. After recovery, the patient complained of tingling and stiffness in the left leg, accompanied with movement disorders and foot drop. Lumbar magnetic resonance imaging was normal. After receiving 500 mg intravenous methylprednisolone daily for 72 hours, she was discharged from the hospital with no particular problems.
Conclusion Foot drop is a neurological disorder, which occurs following natural childbirth and spinal anesthesia due to direct needle trauma or local anesthetic toxicity. This complication is transient and usually resolves within a few days. In our patient, the neurological complication appeared after labor and anesthesia recovery, which was treated by corticosteroids and anti-inflammatory drugs, with no particular side effects.
Keywords: foot drop, cesarean section, spinal anesthesia Introduction Neurological complications following regional anesthesia are uncommon. The prevalence of these complications is estimated to be 0-36 per 10,000 epidural anesthesia cases and about 35 per 10,000 spinal anesthesia cases.1,2 These complications occur in 20% of postpartum women, with only 0.2% being clinically significant.3 Generally, a few neurological complications are reported after cesarean section.4 Subarachnoid block is a common and safe method for the delivery of the anesthetic. In a 2-year study by Scott and Tunstall, neurological disorders were reported in eight out of 14,856 deliveries with spinal anesthesia (0.054%), all of which were transient.5 Moreover, in one study, neurological disorders were reported in 24 cases, with a prevalence of 0.06% after spinal anesthesia and 0.02% after epidural anesthesia.6 Foot drop arises from lumbosacral trunk injury and damage to the common fibular nerve. The symptoms of this neurological disorder, which often occurs in mothers of short stature with fetal macrosomia, include unilateral movement disorders of the ankles with sensory impairment or paresthesia; however, this type of complication is rare after cesarean section.7 Herein, we present a case of foot drop following spinal anesthesia for cesarean delivery. We obtained written informed consent from the patient for publication of her case details and as per the specifications of the journal.
Case presentation A 37-year-old woman (G1P0AB0L0) with 181 cm height and 88 kg weight presented to our clinic for cesarean section due to fetal distress. She had no history of cardiopulmonary, nervous, or sensory motor problems before the cesarean section. The preanesthetic examination indicated the following results: a body temperature of 36.5°C, 17 breaths/min, 78 beats/min, and a blood pressure of 120/80 mmHg. Moreover, preoperative routine coagulation results were normal (international normalized ratio=1).
On fetal ultrasonography, cephalic presentation and a normal anterior placenta (grade II) were reported (amniotic fluid index, 105 mm; estimated fetal weight, 3,150 g). The spinal anesthesia was performed after obtaining the mother's consent. She was initially monitored in terms of electrocardiography, peripheral capillary oxygen saturation, and noninvasive blood pressure. Then, 500 mL of 0.9% normal saline was administered. Spinal anesthesia was induced in the sitting position, using a 25-guage pencil-point spinal needle. The needle was inserted into the L3-L4 space and, after withdrawal of the cerebrospinal fluid, 3 mL of 0.5% bupivacaine was injected. Following needle removal, her position was immediately changed to the supine position.
Spinal anesthesia was induced without any incidents, pain, or paresthesia at the time of needle insertion or local anesthetic injection. After 5 minutes and attaining an upper sensory level of T4, the cesarean section was performed without any significant blood pressure changes on ~40 minutes. During operation, we infused 1,500 mL of 0.9% saline again with 700 mL hemorrhage. The patient had no significant hypotension, and we did not inject vasopressor. After 90 minutes, the nerve block was on T10 level, and on 2.5 hours, the patient had no foot anesthesia and could move and flex her knees.
Following the cesarean section and recovery from spinal anesthesia, the patient reported tingling and paresthesia of the left lower limb. Upon examination, the right dorsiflexion was normal, whereas the left dorsiflexion was reduced to the II/V level. The right plantar flexion was normal, whereas the left plantar flexion was reduced to II/V. The patient complained of foot drop, and her left ankle was immobile with reduced leg muscle strength (II/V). Other than the left foot drop, there were no other sensory and motor symptoms in upper left leg. Sensory and motor examinations were normal in the right leg. Lumbar magnetic resonance imaging (MRI) results were reported to be normal. The electromyography (EMG) showed reduced conduction velocity, besides increased latency and frequency in the lumbar region.
A 500 mg intravenous methylprednisolone was prescribed daily for 3 days and was gradually reduced over the next days. The patient's foot drop was resolved in about 72 hours. She had no other problems and was discharged 3 days after cesarean section. After 1 week, she referred no related signs to the clinic, and the neurological examination was normal.
Discussion Spinal anesthesia is commonly used for cesarean delivery. The most common side effects of this method include hemodynamic changes, nausea and vomiting, back pain, and headache. Neurological complications following spinal anesthesia are rare and transient, with a prevalence of about 3.5%.1 So far, rare cases of permanent neurological complications have been reported. The most common causes of these complications include direct needle trauma and local anesthetic-induced neurotoxicity.
In one study, 24 out of 71,053 patients with neuraxial blocks had neurological complications.6 Paresthesia due to needle placement or injection and repeated attempts were major contributors of lumbosacral nerve injury.8,9 Moreover, in another study, two-thirds of patients with neurological complications experienced pain during needle placement or local anesthetic injections. Needle size, anesthetic dose, and local anesthetic type have been shown to be effective in the development of neurological complications. Moreover, there are variations in the natural anatomical status of the spinal conus. Therefore, when it is located lower in the spinal cord, neurological complications are more common.
Foot drop is normally associated with common peroneal nerve damage, radiculopathy, relative sciatic nerve lesions, lumbosacral lesions, or cauda equina syndrome.10 Other causes include epidural hematoma, epidural abscess, meningitis, and anterior spinal artery syndrome. In a long-term retrospective study, 17 out of more than 10,000 patients with spinal blockade had permanent neurological complications for up to 1 year.11 Neurological paralysis in labor is three to four times more common after regional anesthesia. This postpartum injury occurs due to pressure between the fetal head and sacral trunk, which is the result of an inappropriate lithotomy position.
Neurological complications following spinal anesthesia are due to direct needle or catheter trauma, besides direct intraneural injection of the local anesthetic. These complications may develop as radiculopathy of a single nerve root and are often transient.1,12 In one study, the prevalence of neurological complications was nearly one in 1,000 cases.1 Moreover, in a case report, neurological complication was seen in knee replacement surgery after combined spinal and epidural anesthesia. Pain and paresthesia were attributed to the needle insertion, not drug injection.13 Differential diagnosis of foot drop should be performed to detect complications of the central and peripheral nervous systems by conducting neural and EMG evaluations, as well as MRI studies, to investigate space-occupying lesions. Intense and long-term hemodynamic changes are among the factors, which cause spinal cord ischemia and spinal artery thrombosis, involved in neurological complications. In the present case, no specific hemodynamic changes were observed during surgery or spinal blockade. In some studies, a long-lasting lateral position was the cause of sciatic neuropathy.14,15 But in our report, surgery lasted less than half an hour, and the patient was not in the lateral position for a long time.
The onset, recovery time rate, and extent of neurological symptoms vary among patients. In a study by Auroy et al on 103,000 patients with spinal blockade, all neurological problems initiated within 48 hours, and recovery took from 2 days to 3 months.6 In our case, the complication appeared immediately after recovery from spinal anesthesia and the patient recovered after 72 hours.
In conclusion, we described the case of a patient who experienced unilateral foot drop after spinal anesthesia. This neurological complication appeared after cesarean section and was treated by corticosteroids and anti-inflammatory drugs, with no particular side effects.
References
1. Brooks H, May A. Neurological complications following regional anaesthesia in obstetrics. BJA CEPD Rev. 2003;3(4):111-114. [Google Scholar]
2. Moen V, Irestedt L. Neurological complications following central neuraxial blockades in obstetrics. CurrOpinAnaesthesiol. 2008;21(3):275-280. [PubMed] [Google Scholar]
3. Dar AQ, Robinson AP, Lyons G. Postpartum neurological symptoms following regional blockade: a prospective study with case controls. Int J ObstetAnesth. 2002;11(2):85-90. [PubMed] [Google Scholar]
4. Rorarius M, Suominen P, Haanpaa M, et al. Neurologic sequelae after caesarean section. Acta Anaesthesiol Scand. 2001;45(1):34-41. [PubMed] [Google Scholar]
5. Scott DB, Tunstall ME. Serious complications associated with epidural/spinal blockade in obstetrics: a two-year prospective study. Int J ObstetAnesth. 1995;4(3):133-139. [PubMed] [Google Scholar]
6. Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anesthesia: results of a prospective survey in France. Anesthesiology. 1997;87(3):479-486. [PubMed] [Google Scholar]
7. O'Neal MA, Chang LY, Salajegheh MK. Postpartum spinal cord, root, plexus and peripheral nerve injuries involving the lower extremities: a practical approach. AnesthAnalg. 2015;120(1):141-148. [PubMed] [Google Scholar]
8. Faccenda KA, Finucane BT. Complications of regional anaesthesia incidence and prevention. Drug Saf. 2001;24(6):413-442. [PubMed] [Google Scholar]
9. Horlocker TT. Complications of spinal and epidural anesthesia. Anesthesiol Clin North America. 2000;18(2):461-485. [PubMed] [Google Scholar]
10. Reynolds F. Damage to the conus medullaris following spinal anaesthesia. Anaesthesia. 2001;56(3):238-247. [PubMed] [Google Scholar]
11. Dripps RD, Vandam LD. Long-term follow-up of patients who received 10,098 spinal anesthetics: failure to discover major neurological sequelae. J Am Med Assoc. 1954;156(16):1486-1491. [PubMed] [Google Scholar]
12. Nirmala B, Kumari G. Foot drop after spinal anaesthesia: a rare complication. Indian J Anaesth. 2011;55(1):78-79. [PMC free article] [PubMed] [Google Scholar]
13. Uzunlar H, Duman E, Eroglu A, Topcu B, Erciyes N. A case of "foot drop" following combined spinal epidural anesthesia. Int J Anesthesiol. 2003;8(1):11340. [Google Scholar]
14. Roy S, Levine AB, Herbison GJ, Jacobs SR. Intraoperative positioning during cesarean as a cause of sciatic neuropathy. Obstet Gynecol. 2002;99(4):652-653. [PubMed] [Google Scholar]
15. Postaci A, Karabeyoglu I, Erdogan G, Turan O, Dikmen B. A case of sciatic neuropathy after caesarean section under spinal anaesthesia. Int J ObstetAnesth. 2006;15(4):317-319. [PubMed] [Google Scholar] Foot drop after spinal anaesthesia: A rare complication BC Nirmala and Gowri Kumari Author information Copyright and License information Disclaimer We report a case of foot drop following spinal anaesthesia. As such, neurological complications for central neuraxial blocks are less common. At the time of spinal anaesthesia, if the patient complains of pain or paraesthesia, watch these cases postoperatively carefully for any neurological deficit. The most likely cause in our case is neurotrauma.
A healthy 28-year-old adult female was scheduled for diagnostic laparoscopy. She had no other medical comorbidity history. After obtaining informed written consent and after overnight fasting, she was pre-medicated with tab lorazepam 2 mg, tab ranitidine 150 mg and tab ondensetron 4 mg at 6 AM on the day of surgery (3 h before shifting to the operating room).
In the operative room, an intravenous (IV) access was obtained with a 18 g cannula and monitoring with electrocardiogram (ECG), pulse oximetry and non invasive blood pressure (NIBP) were initiated. With all aseptic precautions a 25g Quincke needle was inserted in the L3-L4 interspace. As the needle entered the subarachnoid space, the patient presented a jerky reaction and complained of paraesthesia and pain. Immediately, the needle was withdrawn, following which the pain subsided instantaneously and she was comfortable. A second time, the needle was placed in the L3-L2 interspace uneventfully. There was good cerebrospinal fluid flow and 3 ml of 0.5% bupivacaine with 25 μg of fentanyl[1] were injected. Inj midazolam 1 mg was given intravenously. The laparoscopic procedure lasted for 35 min. Intraoperative hypotension was managed with Inj ephedrine and her haemodynamic values were maintained stable. The patient was lightly sedated and comfortable throughout.
Postoperatively, approximately after 4 h, the patient was ambulated for passing urine. Then, she noticed that she was unable to move her right foot and the left foot was normal. On examination, she had weakness of the right foot. The case was referred to the neurology department. They diagnosed right-sided foot drop (4/5) and started her on steroids nonsteroidal anti-inflammatory drugs (NSAID) and B-complex. Neurological examination was performed every 4th hourly[2,3] to observe for any progressive weakness. The patient's neurological symptoms were nonprogressive. On the following day, magnetic resonance imaging was performed, which showed no abnormality [Figure 1]. She was discharged with advice of physiotherapy and to continue steroids NSAID and B-complex on the 5th day.
Figure 1 Normal magnetic resonance imaging In the follow-up after 4 weeks, she had partial recovery of (3/5) motor power and 8 weeks later, she had complete recovery.
Spinal anaesthesia with opioids provides excellent surgical conditions for short laparoscopic surgeries.[4] During neuraxial blockade, trauma to the nerve roots or spinal cord could be the cause for paraesthesia and pain. Needle trauma or accidental wrong drug placement are the probable causes for neurological complications following spinal anaesthesia.
Nerve conduction studies are useful in the localization and assessment of nerve injury. Electromyography studies are an adjunct to nerve conduction studies. Signs of denervation on the electromyogram (EMG) after acute nerve injury require 18-21 days to develop.
However, the type and extent of nerve injury vary with the orientation of the needle. When the bevel is parallel to the long axis of the nerve, the needle more readily pass between the fibres. When the needle is transverse to the nerve fibre, the injury is greater.[5] Some sensory disturbances and occasional weakness may last for more than a year.
When paraesthesia is elicited as the needle advances, one can be reasonably certain that a nerve root has been struck. Paraesthesia and its intensity may serve as a warning sign and a guide for severity of nerve injury. Never inject any drug when the patient complains of pain, as an intraneural injection is painful and forebodes permanent damage.
REFERENCES
1. Hamber EA, Viscomi CM. Intrathecal lipophlic opioids as adjuncts to surgical spinal anaesthesia. Reg Anesth Pain Med. 1999;24:255-63. [PubMed] [Google Scholar]
2. Reynold's F. Damage to the conus medullaris following spinal anaesthesia. Anaesthesia. 2001;56:238-47. [PubMed] [Google Scholar]
3. Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anaesthesia: Results of a prospective survey in France. Anaesthesiology. 1997;87:479-86. [PubMed] [Google Scholar]
4. de Santiago J, Santos-Yglesias J, Giron J, Montes de Oca F, Jimenez A, Diaz P. Low dose 3mg levobupivacaine plus 10μg fentanyl selective spinal anaesthesia for gynecological outpatient laparoscopy. AnesthAnalg. 2009;109:1456-61. [PubMed] [Google Scholar]
5. Selander D, Dhuner KG, Lundborg G. Peripheral nerve injury due to injection needles used for regional anaesthesia. An experimental study of the acute effects of needle point trauma. Acta Anaesthesiol Scand. 1997;21:182-8. [PubMed] [Google Scholar] A Rare Case of Transient Foot Drop Post Spinal Anesthesia Aaina Malhotra* and Nagaraj Kandgal *Correspondence: Aaina Malhotra, Department of Anesthesiology and Critical Care, K S Hegde Medical Academy, Mangalore, Karnataka, India, Tel: +91 9988529823, Email:
Author info » Abstract The preferred anesthetic technique for cesarean section is spinal anesthesia. Neurological complications following spinal anesthesia are very rare and often transient. Here we present the case of 23 yr old female who underwent emergency LSCS under spinal anesthesia and developed foot drop 48 hours post operatively. Patient was thoroughly evaluated and started on rehabilitation and followed up regularly. Early clinical assessment and diagnostic interventions is of prime importance to establish the etiology and to start appropriate management.
Keywords Spinal anesthesia; Neurological complications; Rehabilitation Introduction The most common technique of anesthesia for caesarean section is subarachnoid block also known as spinal anesthesia. Neurological complications following regional anesthesia are rare. The prevalence of these complications following epidural anesthesia and spinal anesthesia is about 0-36 per 10,000 and 35 per 10,000 cases respectively [1,2]. In a study conducted by Scott and Tunstall, the neurological deficits were reported in 8 out of 14,856 deliveries with subarachnoid block (0.054%), all of which were transient [3]. Foot drop is caused by injury to lumbosacral trunk and damage to common peroneal nerve. The symptoms of this neurological disorder include unilateral movement disorders of the ankles with sensory impairment or paresthesia. However, this type of complication is rare after caesarean section [4].
Case Report A 23 yr old primigravida at 40 weeks of GA with 150 cm height and 57 kg weight was posted for emergency caesarean section due to grade 3 meconium stained liquor. Thorough preanesthetic check-up was performed and routine investigations performed according to institutional protocol were checked. Patient was categorized into ASA physical status 2. After taking written informed consent, patient was shifted to operation room, standard ASA monitors were attached and IV fluid started via 18G cannula in left upper limb. Patient was positioned in left lateral decubitus position for spinal anesthesia. Under aseptic precautions spinal anesthesia (2 ml of 0.5% hyperbaric bupivacaine) was performed at L3-L4 intervertebral space using a 25G Quinke needle after confirming clear and free flow of CSF. Level of blockade was confirmed with sensory level attained till T4 and motor modified Bromage score 3, after which surgery was started. Duration of surgery was 45 minutes with blood loss of 700 mL and 1500 mL of Ringer Lactate was given i.v. Intra operative period was uneventful and patient was shifted to post anesthesia care unit with stable hemodynamics. After 90 minutes sensory level was T10 and motor blockade returned to modified Bromage score of 0 in 180 mins. Patient was monitored in PACU for a period of 24 hours before shifting towards.
On post op day 2 patients complained of weakness and par aesthesia in the left lower limb. On examination patient had grade 2/5 power of left ankle dorsiflexion and sensory deficit along L4, L5 and S1 dermatomes. Right lower limb was normal on examination. Lumbar MRI was done which was inconclusive. Motor Nerve conduction study of the left lower limb was done (Table 1). Left peroneal nerve F-waves were absent (Table 2). Patient was started on steroids (intravenous methylprednisolone 500 mg daily for 3 days and gradually reduced over the next days), anti-inflammatory drugs, electrical stimulation and physiotherapy. Complete recovery of sensory deficit was achieved by post-operative day 5. Patient was followed up every 7 days for a period of 3 months. Two months post -operatively, patient recovered to power 4/5 and was able to walk without support. Written informed consent was taken from patient for publication of her case details as per journal guidelines.
Nerve Site Latency 1 (ms) Duration (ms) Amplitude (mV) Nerve conduction velocity (m·s−1) Left peroneal nerve Ankle 3.5 10
6.9 52.8 Knee 8.8 10.4 5.6 57.1 Table 1: Motor nerve conduction study.
Nerve Fmin latency (ms) Fmax latency (ms) Fmean latency (ms) Right Peroneal 41 3 38 Left Tibial 43.5 3.4 40.1 Right Tibial 43.4 3.2 40.2 Table 2: F- wave.
Discussion Spinal anesthesia is frequently employed technique for caesarean delivery. The most encountered adverse effects of this technique include hemodynamic changes, back pain, nausea, vomiting, and Post Dural Puncture Headache (PDPH). Neurological complications due to spinal anesthesia are uncommon and short-lived. The prevalence is about 3.5% [1]. The causes for neurological adverse effects are direct needle trauma, local anesthetic-induced neurotoxicity and hematoma.
In a study, 24 of the 71,053 patients with neuraxial blocks had neurological deficits [5]. Repeated attempts, needle placement or injection contributed to lumbosacral nerve injury leading to paraesthesia [6,7]. A similar study showed that two-thirds of patients who had neurological adverse effects complained of pain during needle placement or local anesthetic injections.
Foot drop usually occurs as a result of injury to common peroneal nerve, sciatic nerve injury radiculopathy, lumbosacral lesions, or cauda equina syndrome [8]. Epidural hematoma, epidural abscess, meningitis, and anterior spinal artery syndrome are some more causes of foot drop. A retrospective study showed that 17 out of more than 10,000 patients with subarachnoid blockade had permanent nerve deficits for up to 1 year [9]. Nerve paralysis following labor is three to four times more common after regional anesthesia. The common cause for postpartum nerve injury includes pressure between the fetal head and sacral trunk, which occurs as a result of an inappropriate lithotomy position.
The early diagnosis of postoperative foot drop can be made in susceptible patients by thorough follow up and clinical examination. Magnetic Resonance Imaging (MRI) has to be done to confirm spinal injury. The Nerve conduction study and electromyography is advised to know its neurological or muscular origin respectively. Timely start of anti-inflammatory agents and physiotherapy form an integral part of treatment of these complications.
The onset, recovery time rate, and extent of neurological symptoms vary among patients. In a study by Auroy et al. on 1,03,000 patients with subarachnoid blockade, the neurological deficits began to appear within 48 hours, and their recovery took from 2 days to 3 months [5]. In our case, the complication appeared 48 hours after recovery from spinal anesthesia and the patient regained 75% of ankle function 2 months post operation.
Conclusion We advise a thorough neurological examination of the lower limbs before performing spinal anesthesia. It is important for immediate diagnosis of acutely developed foot drop following spinal anesthesia as early initiation of treatment is essential for improved long term outcomes in such patients.
References Brooks H, May A. Neurological complications following regional anaesthesia in obstetrics. BJA CEPD Rev. 2003;3(4): 111-114.
Moen V, Irestedt L. Neurological complications following central neuraxial blockades in obstetrics. CurrOpinAnaesthesiol. 2008;21(3): 275-280.
Scott DB, Tunstall ME. Serious complications associated with epidural/ spinal blockade in obstetrics: A two-year prospective study. Int J ObstetAnesth. 1995;4(3): 133-139.
O'Neal MA, Chang LY, Salajegheh MK. Postpartum spinal cord, root, plexus and peripheral nerve injuries involving the lower extremities: A practical approach. AnesthAnalg. 2015;120(1): 141-148.
Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anesthesia: Results of a prospective survey in France. Anesthesiology. 1997;87(3): 479-486.
Faccenda KA, Finucane BT. Complications of regional anaesthesia incidence and prevention. Drug Saf. 2001;24(6): 413-442.
Horlocker TT. Complications of spinal and epidural anesthesia. Anesthesiol Clin North America. 2000;18(2): 461-485.
Reynolds F. Damage to the conus medullaris following spinal anaesthesia. Anaesthesia. 2001;56(3): 238-247.
Dripps RD, Vandam LD. Long-term follow-up of patients who received 10,098 spinal anesthetics: Failure to discover major neurological sequelae. J Am Med Assoc. 1954;156(16): 1486-1491.
Now we come to the oath that is taken by a doctor before entering into the number of of medical science and we will also see the maxim res ipsa loquitur.
As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confined in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain by all means in my power, the honour and noble traditions of medical profession.
I will treat my colleagues with all respect and dignity.
I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ? It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence. The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).
In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent.This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
The thing speaks for itselfis the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.
The injury caused to the plaintiff shall be a result of an act of negligence.
There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
The defendant owes a duty of care towards the plaintiff, which he has breached.
There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur.
The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In AchutraoHaribhauKhodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn't exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:
The event doesn't normally occur unless someone has acted negligently;
The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. { MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 } In A.S. Mittal &Anr Vs State Of UP &Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligenceleads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest. Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. TrimbakBapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%.
Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.
Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary.
The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr. Kaushik Nandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.
The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.
Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs.
Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Hon'ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon'ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.KaushikNandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.
The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.
Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.
The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.
There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals.
On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded ofto Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them.
In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:
Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].
Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation .
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default.
In this case the circumstances speak themselves. It is a clear-cut case of negligence and carelessness on the part of the opposite parties .It clearly seems that none of the lower part has been pricked due to negligence or carelessness.Post-operative care should have been observed but in this case we see lack of post-operative care. If you have been a few home every paraphernalia should be there. There is delay in diagnosing the actual problem.
Immediate postoperative care:
Now an action arises whether there was proper post-operative care taken by the opposite parties after the operation and after the complication developed in the body of the patient.
Postoperative patients must be monitored and assessed closely for any deterioration in condition and the relevant postoperative care plan or pathway must be implemented.
The NCEPOD (2011) report found that patients whose condition was deteriorating were not always identified and referred for a higher level of care. Patients should be made ascomfortable as possible before postoperative checks are performed.
Postoperative patients are at risk of clinical deterioration, and it is vital that this is minimized. Knowledge and understanding of the key areas of risk and local policies will help reduce potential problems (National Patient Safety Agency, 2007; National Institute for Health and Clinical Excellence, 2007).
Track and trigger or early warning systems are widely used in the UK to identify deteriorating patients. These have been adapted by trusts for adults and children and are based on the patient's pulse and respiratory rate, systolic blood pressure, temperature and level of consciousness. Additional monitoring may include pain assessment, capillary refill time, percentage of oxygen administered, oxygen saturation, central venous pressure, infusion rates and hourly urine output.
The National Early Warning Score (NEWS) was developed by a working party to provide a national standard for assessing, monitoring and tracking acutely and critically ill patients (not for use with children under 16 years or in pregnancy); the intention was that trusts would use it to replace their locally adapted early warning systems (Royal College of Physicians, 2012). Like other early warning systems, NEWS has six physiological parameters:
Respiratory rate;
Oxygen saturation;
Temperature;
Systolic blood pressure;
Pulse rate;
Level of consciousness (this will be impaired in patients who have had recent sedation or are receiving opioid analgesia, which should be taken into consideration in assessment).
The system also includes a weighting score of two, which is added if the patient is receiving supplemental oxygen via a mask or nasal cannulas.
When assessing the postoperative patient using NEWS, it is vital that the patient is observed for signs of hemorrhage, shock, sepsis and the effects of analgesia and anesthetic. Patients receiving intravenous opiates are at risk of their vital signs and consciousness levels being compromised if the rate of the infusion is too high. It is therefore imperative that the patient's pain control is managed well, initially by the anesthetist and then the ward staff and pain team or anesthetist, to ensure that the patient has adequate analgesia but is alert enough to be able to communicate and cooperate with clinical staff in the postoperative period.
Many trusts have yet to implement NEWS, although it is beginning to be taught in pre-registration nursing programmes. Student nurses frequently perform postoperative observations under the supervision of a nurse; it is reassuring that they receive some insight and education as recommended by NCEPOD (2011).
Vital signs;
Vital signs should be performed in accordance with local policies or guidelines and compared with the baseline observations taken before surgery, during surgery and in the recovery area.
Nurses should also be aware of the parameters for these observations and what is normal for the patient under observation. When assessing patients' recovery from anaesthesia and surgery, these observations should not be considered in isolation; the nurse should look at and feel the patient. This also applies to children and should include observation of other signs and symptoms, for example abdominal tenderness or poor urine output, which could indicate deterioration (Royal College of Nursing, 2011). The RCN (2011) provides guidance on vital signs performed post-operatively on children. Many trusts now insist that vital signs are performed manually to provide more accurate recording and assessment.
All vital signs and assessments should be recorded clearly in accordance with guidelines for record keeping (Nursing and Midwifery Council, 2009). Handheld personal digital assistants (PDAs) are used at some trusts to store track and trigger data and calculate early warning scores, which can be accessed by the clinical and outreach teams.
When a patient's condition is identified as deteriorating, this information can be passed verbally to appropriate health professionals using the Situation, Background, Assessment and Recommendation (SBAR) tool advocated by the NHS Institute for Innovation and Improvement (2008).
Airway and respirations Respiratory rate and function is often the first vital sign to be affected if there is a change in cardiac or neurological state. It is therefore imperative that this observation is performed accurately; however, studies show it is often omitted or poorly assessed (NPSA, 2007; NCEPOD, 2005).
Nurses should observe and record the following:
Airway;
Respiratory rate (regular and effortless), rhythm and depth (chest movements symmetrical);
Respiratory depression: indicated by hypoventilation or bradypnoea, and whether opiate-induced or due to anaesthetic gases.
Oxygen therapy Oxygen is administered to enable the anaesthetic gases to be transported out of the body, and is prescribed when patients have an epidural, patient-controlled analgesia or morphine infusion. Nurses should ensure and record the following:
Oxygen therapy is prescribed;
Oxygen is administered at correct rate;
Continuous oxygen therapy is humidified to prevent mucous membranes from drying out;
The skin above the ears is protected from elastic on the mask.
Pulse oximetry Oxygen saturation should be above 95% on air, unless the patient has lung disease, and maintained above 95% if oxygen therapy is prescribed to prevent hypoxia or hypoxaemia. An abnormal recording may be due to shivering, peripheral vasoconstriction or dried blood on the finger.
Nurses should ensure that:
The finger probe is clean;
The position of the probe is changed regularly to prevent fingers becoming sore.
Heart rate, blood pressure and capillary refill time The following should be checked and recorded:
Rate, rhythm and volume of pulse;
Blood pressure;
Capillary refill time to assess circulatory status, along with the colour and temperature of limbs, also identifying reduced peripheral perfusion.
Particular attention should be paid to the systolic blood pressure as a lowered systolic reading and tachycardia may indicate haemorrhage and/or shock, although initially the blood pressure may not drop and will remain within normal limits as the body compensates. Tachycardia may also indicate that the patient is in pain, has a fluid overload or is anxious. Hypertension can be due to the anaesthetic or inadequate pain control.
Body temperature Children, older adults and patients who have been in theatre for a long period are at risk of hypothermia. Shivering can be due to anaesthesia or a high temperature indicative of an infection, while a drop in temperature might indicate a bacterial infection or sepsis.
Patients' temperature should be monitored closely and action taken to return it to within normal parameters.
Use a Bair Hugger (forced-air blanket) and blankets to warm the patient if their temperature is too low;
Choose an appropriate method to cool the patient if their temperature is too high (antipyretics/fanning/ tepid sponging).
Level of consciousness .
Postoperative patients should respond to verbal stimulation, be able to answer questions and be aware of their surroundings before being transferred to the ward and throughout the postoperative period.
A change in the level of consciousness can be a sign that the patient is in shock. The AVPU scale (Box 2) is appropriate for assessing consciousness in adults, children and young people unless they have had neurosurgery (RCN, 2011).
Fluid balance The NCEPOD (2011) found, in 30% of patient data reviewed, there was insufficient recording of postoperative fluid balance. Nurses should observe/undertake and record on the fluid balance chart the following:
IV fluids (colloids and crystalloids used to replace fluid loss postoperatively) and infusions;
Oral intake;
Urine output: catheter urine measurements should not be less than 0.5ml/kg/hour. Oliguria can be a sign of hypovolaemia and should be reported to medical staff immediately. Check that the catheter is not kinked or that the patient is not lying on the tubing if urine output is reduced;
Colour of stoma (where appropriate) and whether there is any bleeding;
Nausea and vomiting: if necessary, administration of antiemetics should be checked and vomit bowls and tissues should be within easy reach of the patient;
Oral care;
Nasogastric tube drainage (aspirate if patient feels nauseous unless otherwise indicated);
Colour and amount of wound drainage: large amounts of fresh blood could be an indication of haemorrhage; if there is no wound drainage, it is advisable to check that the drain has not fallen out.
Intravenous infusions The RCN (2010) and Health Protection Scotland (2012) recommend that peripheral venous catheters (PVC) are checked daily as a minimum, and consideration given to removing any PVC that has been in situ longer than 72 hours (Health Protection Scotland, 2012) or 72-96 hours (Department of Health, 2011).
A phlebitis scale can be used to help assess the PVC site; the Visual Infusion Phlebitis Scale (Jackson, 1998) is frequently used and recommended by the RCN (2010). These national guidelines should be used as resources in caring for PVCs. The following should be checked and recorded:
The PVC site when changing IV fluids, before administering IV medication;
Signs of phlebitis (redness, heat and swelling).
Conclusion The postoperative healthcare team is under constant pressure to discharge patients quickly. This can lead to vital signs being missed and result in a delay in recovery.
Patients can be discharged quickly only when they do not experience any post-operative complications, many of which can be avoided or identified with correct and thorough monitoring of signs and symptoms.
All health professionals must continually update their theoretical knowledge and clinical skills; those working in post-operative care can do this by relying less on electronic equipment and developing their ability to combine the use of assessment tools with good observational skills; feeling, listening for abnormal sounds and closely observing their patients.
There are guidelines issued by World Health Organisation for Post Operative Care - these are Postoperative care Post operative note and orders The patient should be discharged to the ward with comprehensive orders for the following:
• Vital signs • Pain control • Rate and type of intravenous fluid • Urine and gastrointestinal fluid output • Other medications • Laboratory investigations The patient's progress should be monitored and should include at least:
• A comment on medical and nursing observations • A specific comment on the wound or operation site • Any complications • Any changes made in treatment Aftercare: Prevention of complications • Encourage early mobilization:
o Deep breathing and coughing o Active daily exercise o Joint range of motion o Muscular strengthening o Make walking aids such as canes, crutches and walkers available and provide instructions for their use • Ensure adequate nutrition • Prevent skin breakdown and pressure sores:
o Turn the patient frequently o Keep urine and faeces off skin • Provide adequate pain control Discharge note On discharging the patient from the ward, record in the notes:
• Diagnosis on admission and discharge • Summary of course in hospital • Instructions about further management, including drugs prescribed.
Ensure that a copy of this information is given to the patient, together with details of any follow-up appointment .
(WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 Postoperative Management) If the patient is restless, something is wrong.
Look out for the following in recovery:
• Airway obstruction • Hypoxia • Haemorrhage: internal or external • Hypotension and/or hypertension • Postoperative pain • Shivering, hypothermia • Vomiting, aspiration • Falling on the floor • Residual narcosis The recovering patient is fit for the ward when:
• Awake, opens eyes • Extubated • Blood pressure and pulse are satisfactory • Can lift head on command • Not hypoxic • Breathing quietly and comfortably • Appropriate analgesia has been prescribed and is safely established (WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 ) Post operative pain relief • Pain is often the patient's presenting symptom. It can provide useful clinical information and it is your responsibility to use this information to help the patient and alleviate suffering.
• Manage pain wherever you see patients (emergency, operating room and on the ward) and anticipate their needs for pain management after surgery and discharge.
• Do not unnecessarily delay the treatment of pain; for example, do not transport a patient without analgesia simply so that the next practitioner can appreciate how much pain the person is experiencing.
Pain management is our job.
Pain Management and Techniques • Effective analgesia is an essential part of postoperative management.
• Important injectable drugs for pain are the opiate analgesics. Nonsteroidal antiinflammatory drugs (NSAIDs), such as diclofenac (1 mg/kg) and ibuprofen can also be given orally and rectally, as can paracetamol (15 mg/kg).
• There are three situations where an opiate might be given: o Preoperatively o Intraoperatively o Postoperatively • Opiate premedication is rarely indicated, although an injured patient in pain may have been given an opiate before coming to the operating room.
• Opiates given pre- or intraoperatively have important effects in the postoperative period since there may be delayed recovery and respiratory depression, even necessitating mechanical ventilation.
• Short acting opiate fentanyl is used intra-operatively to avoid this prolonged effect.
• Naloxone antagonizes (reverses) all opiates, but its effect quickly wears off.
• Commonly available inexpensive opiates are pethidine and morphine.
• Morphine has about ten times the potency and a longer duration of action than pethidine.
(continued next page) WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003) Post operative pain relief (continued) • Ideal way to give analgesia postoperatively is to:
o Give a small intravenous bolus of about a quarter or a third of the maximum dose (e.g. 25 mg pethidine or 2.5 mg morphine for an average adult) o Wait for 5-10 minutes to observe the effect: the desired effect is analgesia, but retained consciousness o Estimate the correct total dose (e.g. 75 mg pethidine or 7.5 mg morphine) and give the balance intramuscularly.
o With this method, the patient receives analgesia quickly and the correct dose is given • If opiate analgesia is needed on the ward, it is most usual to give an intramuscular regimen:
¾ Morphine: - Age 1 year to adult: 0.1-0.2 mg/kg - Age 3 months to 1 year: 0.05-0.1 mg/kg ¾ Pethidine: give 7-10 times the above doses if using pethidine • Opiate analgesics should be given cautiously if the age is less than 1 year. They are not recommended for babies aged less than 3 months unless very close monitoring in a neonatal intensive care unit is available.
Now again we come to this case. The complainant has stated that she has become handicapped and 60%. The certificate of the sub and has also been filed which is scanned here.
So from the above facts and circumstances of the case we are of the opinion that there is lack of knowledge in the field of anaesthesia. If anaesthesia pricking creates electric shock in the legs, it should have been aborted but in this case the opposite party - 3 did not abort but again tried her best which ultimately resulted in drop foot. The patient could not be handled with proper care and precautions as per medical protocol. All the reports of MRI shows that opposite parties are totally negligent in this case. The maxim res ipsa loquitur is fully apply in this case. Circumstances speak themselves. The complainant having a little problem of hypothyroidism has been made permanent disabled by 60% by the opposite parties. Think about the life of her. She has become unable to move without the help of any person. Doctors do their best but sometimes they show the negligence of the extreme level. This is the case where the opposite parties have shown extreme level of negligence and carelessness. There was total lack of post-operative care and also preoperative precautions so in the circumstances we are of the opinion that the opposite parties are liable for showing grave negligence. The complainant has prayed for various reliefs and also in the last she has prayed "such other and further relief in addition to the reliefs claimed". In this clause of relief we are of the opinion that as she is disabled by 60% so she should be given ₹ 1 lakh for each percent of disablement that is ₹ 60 lakhs for this disablement because it is a lifelong pain for the complainant and her family members. The complaint case is decided accordingly.
ORDER The opposite parties are jointly and severally directed to pay ₹ 15 lakhs to the complainant towards compensation.
The opposite parties are jointly and severally directed to pay ₹ 10 lakhs to the complainant towards doctors fees, hospital charges, medicines, for different type of tests and travelling.
The opposite parties are jointly and severally directed to pay ₹ 01 lakh to the complainant towards extra nourishment.
The opposite parties are jointly and severally directed to pay ₹ 60 lakhs to the complainant towards permanent burning, sensation, pain, suffering, disfigurement of right leg, services of an attendant, cost of the petition, mental torture and agony.
The opposite parties are jointly and severally directed to pay all the above reliefswith interest at a rate of 10% from 01.01.2019 within 45 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 01.01.2019 till the date of actual payment.
In the order is not complied with, within 45 days the complainant shall be free to file execution proceeding against the opposite parties at their cost.
The stenographer is requested to upload this order on the Website of this Commission today itself.
Certified copy of this judgment be provided to the parties as per rules.
(Vikas Saxena) (Rajendra Singh) Member Presiding Member Judgment dated/typed signed by us and pronounced in the open court. Consign to the Record Room. (Vikas Saxena) (Rajendra Singh) Member Presiding Member Dated : March 09 ,2023 Jafri, PA II [HON'BLE MR. Rajendra Singh] PRESIDING MEMBER [HON'BLE MR. Vikas Saxena] JUDICIAL MEMBER