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   2017| March  | Volume 61 | Issue 3  
    Online since March 15, 2017

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Regulatory requirements for clinical trials in India: What academicians need to know
Nithya J Gogtay, Renju Ravi, Urmila M Thatte
March 2017, 61(3):192-199
DOI:10.4103/ija.IJA_143_17  PMID:28405032
The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as “Investigator- initiated studies” and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with “must know” and “good to know” facets for the conduct of clinical research in the country.
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Post-caesarean analgesia: What is new?
Sukhyanti Kerai, Kirti Nath Saxena, Bharti Taneja
March 2017, 61(3):200-214
DOI:10.4103/ija.IJA_313_16  PMID:28405033
Adequate post-operative analgesia after caesarean section (CS) is vital as it impacts the distinct surgical recovery requirements of the parturient. Although newer analgesic modalities and drugs for post-caesarean analgesia have been introduced over the recent years, review of the literature suggests suggests that we are far from achieving the goals of optimum post-operative analgesia. We conducted a systematic review of recent advances in modalities for post-caesarean analgesia. After systematic search and quality assessment of studies, we included a total of 51 randomised controlled trials that evaluated the role of opioids, transversus abdominis plane (TAP) block, wound infiltration/infusion, ketamine, gabapentin and ilioinguinal-iliohypogastric nerve block (II-IH NB) for post-caesarean analgesia. Administration of opioids still remains the gold standard for post-operative analgesia, but the associated troublesome side effects have led to the mandatory incorporation of non-opioid analgesics in post-CS analgesia regime. Among the non-opioid techniques, TAP block is the most investigated modality of the last decade. The analgesic efficacy of TAP block as a part of multimodal analgesia is established in post-CS cases where intrathecal morphine is not employed and in CS under general anaesthesia. Among non-steroidal anti-inflammatory drugs, COX-I inhibitors and intravenous paracetamol are found to be useful in post-operative analgesic regimen. The perioperative use of ketamine is found useful only in CS done under spinal anaesthesia; no benefit is seen where general anaesthesia is employed. Wound infiltration with local anaesthetics, systemic gabapentin and II-IH NB need further trials to assess their efficacy.
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Supraclavicular brachial plexus block: Comparison of varying doses of dexmedetomidine combined with levobupivacaine: A double-blind randomised trial
Srinivasa Rao Nallam, Sunil Chiruvella, Swetha Karanam
March 2017, 61(3):256-261
DOI:10.4103/ija.IJA_700_15  PMID:28405041
Background and Aims: The ideal dose of dexmedetomidine for brachial plexus block is a matter of debate. This study was carried out to evaluate 50 μg or 100 μg of dexmedetomidine added to 0.5% levobupivacaine, with regard to the duration of analgesia. Our study also sought to assess the onset and duration of sensorimotor blockade, haemodynamic effects, sedation and adverse effects. Methods: One hundred adult patients undergoing upper limb surgeries under supraclavicular brachial plexus block were randomly allocated into two groups. Group LD50 received 29 ml of 0.5% levobupivacaine plus 50 μg of dexmedetomidine diluted in 1 ml of normal saline. Group LD100 received 29 ml of 0.5% levobupivacaine plus 100 μg of dexmedetomidine diluted in 1 ml of normal saline. Duration of analgesia was the primary outcome. Onset and duration of sensorimotor blockade, haemodynamic variables, sedation score, and adverse effects were secondary outcomes. The data were analysed with Students' t-test and Chi-square test. Results: The onset of sensory block and motor block was 14.82 ± 3.8 min and 19.75 ± 6.3 min, respectively, in group LD50, while it was 11.15 ± 1.7 min and 14.3 ± 4.2 min, respectively, in group LD100. The duration of analgesia was significantly prolonged in group LD100 (1033.6 ± 141.6 vs. 776.4 ± 138.6 min; P = 0.001). The incidence of bradycardia and sedation was observed in significantly more patients in group LD100. Significantly fewer patients in group LD100 required rescue analgesia. Conclusion: The 100 μg dose of dexmedetomidine in brachial plexus block hastens the onset and prolongs the duration of sensorimotor blockade and analgesia, but with higher incidence of bradycardia and sedation.
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Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study
Sameer N Desai, Santhoshi V Badiger, Shreesha B Tokur, Prashanth A Naik
March 2017, 61(3):225-229
DOI:10.4103/ija.IJA_208_16  PMID:28405035
Background: Transdermal buprenorphine, which is used in chronic pain management, has rarely been studied for use in acute pain management. The aim of this study was to compare the safety and efficacy of transdermal buprenorphine patch to oral tramadol for post-operative analgesia, following proximal femur surgeries. Methodology: Fifty adult patients undergoing surgery for hip fracture under spinal anaesthesia were included in this study. One group (Group TDB) received transdermal buprenorphine 10 mcg/h patch applied a day before the surgery and other group received oral tramadol 50 mg three times a day for analgesia (Group OT). They were allowed to take diclofenac and paracetamol tablets for rescue analgesia. Pain scores at rest, on movement, rescue analgesic requirement and side effects were compared between the groups over 7 days. Chi-square and independent sample t-test were used for categorical and continuous variables, respectively. Results: Resting pain scores and pain on movement were significantly lower in TDB Group on all 7 days starting from 24 h post-operatively. Rescue analgesic requirement was significantly lower in TDB Group compared to OT Group. All the patients needed rescue analgesic in OT Group whereas 68% of the patients needed the same in TDB Group. Incidence of vomiting was less and satisfaction scores were much higher in TDB Group as compared to OT Group (79% vs. 66%, P < 0.001). Conclusion: Transdermal buprenorphine can be safely used for post-operative analgesia and is more efficacious in reducing post-operative pain after 24 hours, with fewer side effects when compared to oral tramadol.
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Managing acute post-operative pain: Advances, challenges and constraints
Sukhminder Jit Singh Bajwa
March 2017, 61(3):189-191
DOI:10.4103/ija.IJA_110_17  PMID:28405031
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A dose-finding randomised controlled trial of magnesium sulphate as an adjuvant in ultrasound-guided supraclavicular brachial plexus block
Versha Verma, Shelly Rana, Sudarshan Kumar Chaudhary, Jai Singh, Ravinder Kumar Verma, Saloni Sood
March 2017, 61(3):250-255
DOI:10.4103/ija.IJA_466_16  PMID:28405040
Background and Aim: Magnesium sulphate (MgSO4) has been used as an adjuvant in brachial plexus block with encouraging results; however, there is no consensus regarding its optimal dose. Thereby, we compared the efficacy of two doses of MgSO4 as an adjuvant in ultrasound (USG) guided supraclavicular brachial plexus block. Methods: Ninety patients, aged 20–60 years, belonging to American Society of Anesthesiologists physical status 1 or 2, were given USG-guided supraclavicular block. Group B (n = 30) received 20 ml of 0.5%bupivacaine + 5 ml normal saline (NS), Group BM0.5(n = 30) received 20 ml of 0.5%bupivacaine + 3.75 ml NS and 125 mg MgSO4 (1.25 ml) and Group BM1(n = 30) received 20 ml of 0.5%bupivacaine + 2.5 ml NS and 250 mg MgSO4 (2.5 ml). The primary outcome of study was the duration of post-operative analgesia. The normally distributed data were analysed using analysis of variance and categorical data analysed using Chi-square test. Results: Duration of post-operative analgesia was prolonged in Groups BM1 and BM0.5 (665.13 ± 97.874, 475.10 ± 53.294) min respectively as compared to Group B (272.03 ± 40.404 min: P = 0.00). The onset times of sensory and motor block were shorter in Group BM1 (5.17 ± 2.2 min)as compared to Groups BM0.5 and B (8.9 ± 2.3 and 17.7 ± 5.1 min: P = 0.00) respectively. Sensory and motor block durations were prolonged in Group BM1 as compared to BM0.5 and B (P = 0.00). Conclusions: MgSO4 as adjuvant in brachial plexus block increases the duration of post-operative analgesia. MgSO4 in the dose of 250mg has greater efficacy as compared to 125 mg.
  2,608 575 -
A multicentre survey of the current acute post-operative pain management practices in tertiary care teaching hospitals in Maharashtra
Samina Khaliloddin Khatib, Syed Shamim Razvi, Sadhana Sudhir Kulkarni, Swapnil Parab
March 2017, 61(3):215-224
DOI:10.4103/ija.IJA_506_16  PMID:28405034
Background and Aims: Undertreated pain can have negative consequences on patients' health as well as the health-care system. The present study was aimed at identifying the current trends in post-operative pain management and availability of acute pain services (APS). In addition, it is also an attempt to assess the availability of analgesia for non-surgical cases, and the attitudes, beliefs, and perceptions of clinicians regarding acute pain management in the tertiary hospitals in the state of Maharashtra (India). Methods: This was a cross-sectional, multicentre questionnaire survey involving the anaesthesiologists and surgeons. Percentages, median, interquartile ranges were calculated and compared by employing a Wilcoxon sign rank test. Results: Data from thirty centres revealed that the surgeons played a major role in treating pain, while most of the anaesthesiologists treated pain primarily in the operation theatre and recovery room. An APS was operational in seven hospitals. The most frequently employed techniques to achieve analgesia were the administration of non-steroidal anti-inflammatory drugs, opioids and epidural analgesia. The majority of the centres had no written protocol and dedicated staff for pain management, pain assessment was not adequately stressed, and only five out of the thirty centres included in the study provided ongoing pain education to health professionals even when the hospitals claimed to provide APS. The major hurdles in providing optimal analgesia and implementing APS were a lack of pain education, equipment and administrative problems. Conclusion: Thus, the tertiary centres in Maharashtra fall short of providing optimal acute post-operative pain management.
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The effect of different dose regimens of tranexamic acid in reducing blood loss during hip surgery
Anil Kumar Thipparampall, Indira Gurajala, R Gopinath
March 2017, 61(3):235-239
DOI:10.4103/ija.IJA_495_16  PMID:28405037
Background and Aims: Antifibrinolytics may help bleeding in orthopaedic surgeries. The present study was undertaken to compare two dose regimens of tranexamic acid (TA) on perioperative blood loss in patients undergoing hip surgeries. Methods: In a prospective, randomised, controlled study, 59 patients scheduled for hip surgery were divided into Group C: receiving normal saline (n - 20), Group B: receiving single dose of TA (10 mg/kg) (n - 21), and Group I: receiving a bolus (10 mg/kg) plus infusion (1 mg/kg/h) of TA up to 4 h postoperatively (n - 18). Blood loss, haemoglobin and allogeneic blood transfusions were compared between the groups. For parametric data, P was calculated by ANOVA. Intergroup comparison was done by post hoc analysis with Bonferroni test. P < 0.05 was considered significant. Results: The intra-operative blood loss was lower in the patients who received TA (525 ± 150, 456 ± 156 and 400 ± 133 ml in Group C, B and I respectively; P = 0.05). The 6th hourly drain collection in Group I was lower than Group B and C (41 ± 18, 46 ± 14 and 31 ± 14 ml in Group C, B, and I respectively; P = 0.018). The blood loss at 24 h was less in groups receiving TA (146 ± 32, 120 ± 76, 107 ± 37 ml for Group C, B and I, respectively; P = 0.02). The requirement of blood transfusions was lower in Group I. Conclusions: A bolus of tranexamic acid followed by infusion is more useful than a single dose in decreasing perioperative blood loss in patients undergoing hip surgeries. It reduces allogenic blood transfusion without increasing risk of thromboembolic events.
  2,026 493 -
Ultrasonographic measurement of optic nerve sheath diameter: A point of care test helps in prognostication of Intensive Care Unit patients
Arnab Banerjee, Renu Bala, Savita Saini
March 2017, 61(3):262-265
DOI:10.4103/ija.IJA_473_16  PMID:28405042
Early identification of elevated intracranial pressure (ICP) is critical to ensuring timely and appropriate management to improve patient outcome. Measurement of the optic nerve sheath diameter by ultrasound is a well studied modality for noninvasive assessment of ICP. Recent studies have shown it to correlate with invasively measured ICP. We utilized this technique in our ICU and found it to be of great help in guiding patient management and predicting the prognosis. A case series of four patients is reported illustrating its utility in ICU patients.
  2,125 393 -
Incidence of posterior wall penetration during internal jugular vein cannulation: A comparison of two techniques using real-time ultrasound
Shrikanth Srinivasan, Deepak Govil, Sachin Gupta, Sweta Patel, KN Jagadeesh, Deeksha Singh Tomar
March 2017, 61(3):240-244
DOI:10.4103/ija.IJA_632_16  PMID:28405038
Background and Aims: The true incidence of penetration of the posterior wall (through-and-through puncture) of the internal jugular vein (IJV) during cannulation is unknown. This may have implications if there is hematoma formation, penetration and/or inadvertent cannulation of an underlying carotid artery. This study compared the incidence of posterior wall puncture during IJV cannulation using ultrasound guidance versus traditional landmarks-guided technique. Methods: One hundred and seventy adult patients admitted to a gastro-liver Intensive Care Unit who required central venous lines were randomly divided into Group A: IJV cannulation using anatomical landmark-guided technique and Group B: IJV cannulation using real-time ultrasound guidance. In both groups, a second investigator followed the needle path using real-time ultrasound. The incidence of posterior wall puncture, number of attempts for successful cannulation, incidence of inadvertent arterial punctures and occurrence of complications such as hematoma formation and pneumothorax were recorded. Results: Significantly more (37/80, 46%) patients in Group A had posterior wall puncture compared to 19/90 (21%) in Group B. Incidence of arterial puncture was 8/80 (10%) in Group A, 5/90 (5.5%) in Group B. The number of attempts for venous cannulation and hematoma formation was significantly less in Group B. Conclusion: Real-time ultrasound-guided IJV cannulation significantly reduces but does not wholly eliminate the incidence of posterior venous wall penetrations. It also significantly reduces the incidence of inadvertent arterial punctures and number of attempts for successful cannulation.
  1,923 371 -
Disinfection of laryngoscopes: A survey of practice
Vaishali Prabhakar Chaskar, Nandini Malay Dave, Raylene Dias, Priyanka Karnik
March 2017, 61(3):245-249
DOI:10.4103/ija.IJA_347_16  PMID:28405039
Background and Aims: The laryngoscope is a common piece of equipment used by anaesthesiologists. It has been identified as a potential source of cross infection. Although guidelines exist regarding appropriate disinfection practices, recent reviews suggest ineffectiveness of current methods of disinfection and poor compliance with the established protocols. We conducted a questionnaire-based survey to study the current disinfection practices being followed by a cross section of anaesthesiologists. Methods: A simple questionnaire containing 13 questions was distributed amongst anaesthesiologists in an anaesthesia conference. Data were analysed with percentage analysis. Results: Out of 250 delegates who attended the conference, 150 submitted the completed questionnaires. Residents constituted 41% and 46% were consultants. Eighteen (12%) used only tap water for cleaning and 132 (88%) used a chemical agent after rinsing with water. Out of 132, 76 (51%) used detergent/soap solution, 29 (19%) would wash and then soak in disinfectant or germicidal agents (glutaraldehyde, povidone iodine and chlorhexidine) and 18 (12%) would wipe the blade with an alcohol swab. With respect to disinfection of laryngoscope handles, 70% respondents said they used an alcohol swab, 18% did not use any method, 9% were not aware of the method being used, while 3% did not respond. Conclusion: Our results indicate wide variation in methods of decontamination of laryngoscopes. Awareness regarding laryngoscope as a potential source of infection was high. We need to standardise and implement guidelines on a national level and make available resources which will help to improve patient safety.
  1,909 381 -
Rapidity and efficacy of ultrasonographic sliding lung sign and auscultation in confirming endotracheal intubation in overweight and obese patients
Sunil Rajan, Jayasankar Surendran, Jerry Paul, Lakshmi Kumar
March 2017, 61(3):230-234
DOI:10.4103/0019-5049.202164  PMID:28405036
Background and Aims: Obese individuals are predisposed to difficult airway and intubation. They usually yield confusing or misleading auscultatory findings. We aimed to assess the rapidity and efficacy of ultrasonographic (USG) sliding lung sign for confirming endotracheal intubation in normal as well as overweight and obese surgical patients. Methods: This prospective, observational study was performed in forty surgical patients. Twenty patients with body mass index (BMI) <25 were recruited to Group A, whereas twenty patients with BMI ≥25 constituted Group B. Following induction and intubation, appearance of end-tidal carbon dioxide waveform was used to confirm endotracheal intubation. Presence of breath sounds bilaterally was sought by auscultation, and time taken for auscultatory confirmation was noted. The USG confirmation of air entry to the lung field as indicated by lung sliding was sought, and the time taken was noted. Chi-square test, independent t-test and paired t-test were used as applicable. Results: Auscultatory confirmation was more rapid in Group A as compared to Group B (9.34 ± 2.43 s vs. 14.35 ± 5.53 s, P = 0.001). However, there was no significant difference in USG confirmation time in both the groups (8.57 ± 2.05 s vs. 8.61 ± 1.66 s). Four patients in Group B had doubtful breath sounds against none in Group A. There was no doubtful lung slide with USG in both groups. One case of endobronchial intubation in Group B was diagnosed with USG which was doubtful by auscultation. Conclusion: Ultrasound directed confirmation of endotracheal tube placement in overweight and obese patients is superior in speed and accuracy in comparison to the standard auscultatory method.
  1,706 458 -
Alternative use of the ophthalmic drape for anaesthesia procedures
Nitin Bhorkar, Tasneem Dhansura, Urmila Tarawade, Sanchita Mahajan
March 2017, 61(3):271-272
DOI:10.4103/ija.IJA_711_16  PMID:28405045
  1,945 218 -
Anaesthetic management of a child with stone man syndrome: Look before you leap!
Geeta Kamal, Anju Gupta, Sapna Batla, Nishkarsh Gupta
March 2017, 61(3):266-268
DOI:10.4103/0019-5049.202168  PMID:28405043
Stone Man syndrome or fibrodysplasia ossificans progressiva (FOP) is an extremely rare (1 in 2 million) genetic disorder characterised by ectopic ossification of the skeletal and connective tissues leading to progressive fusion of axial and appendicular skeleton. Surgery and anaesthesia-induced trauma can lead to disease flare-up if due precautions are not taken and disable the patient further. However, rarity of the disease may lead to its common misdiagnosis and anaesthesiologist may be caught unaware. There is relative paucity of literature regarding anaesthetic management of children with FOP. Videolaryngoscopes (VLs) provide a non-line-of-sight view and require less anterior force to visualise the glottis, may provide an alternative to fibreoptic intubation for airway management in such cases. Use of VL has only been reported once in an adult with FOP for nasotracheal intubation. We describe the successful anaesthetic management of an 11-year-old child with FOP and anticipated difficult airway.
  1,727 291 -
Another approach for prone positioning under general anaesthesia
Dileep Kumar, Mohammad Hamid, Kelash Kumar
March 2017, 61(3):278-279
DOI:10.4103/ija.IJA_543_16  PMID:28405050
  1,700 272 -
A fatal case of pulmonary embolism after lumbar spine surgery
Gaurav Singh Tomar, Sujoy Banik, Ranadhir Mitra, Rajendra Singh Chouhan
March 2017, 61(3):273-275
DOI:10.4103/0019-5049.202176  PMID:28405047
  1,231 272 -
Congenital factor VII deficiency: Multidisciplinary approach is the key to successful perioperative outcome
Sushama Raghunath Tandale, Sunita M Khedkar, Aparna Hemraj Yadav, Shivankar Ajatshatru
March 2017, 61(3):275-276
DOI:10.4103/ija.IJA_2_17  PMID:28405048
  1,282 208 -
Nasal septal perforation diagnosed intraoperatively by course of nasotracheal tube from left nostril to right nostril
Sohan Lal Solanki, Jeson R Doctor, Shreyans Shah
March 2017, 61(3):280-281
DOI:10.4103/ija.IJA_668_16  PMID:28405051
  1,147 195 -
Use of malfunctioning fibre-optic bronchoscope as a rescue bougie!
Abinash Patro, Vansh Priya, Rafat Shamim, Prabhat Kumar Singh
March 2017, 61(3):277-278
DOI:10.4103/ija.IJA_559_16  PMID:28405049
  1,122 167 -
Is our suction apparatus rightly calibrated?
Shweta Panse, Sheetal Chiplonkar, Tista Ganguly
March 2017, 61(3):272-273
DOI:10.4103/ija.IJA_568_16  PMID:28405046
  1,032 185 -
Salami publishing and ethical dilemmas facing editors
Satyen Parida
March 2017, 61(3):269-270
DOI:10.4103/ija.IJA_710_16  PMID:28405044
  962 165 -
Lighter planes

March 2017, 61(3):282-282
Full text not available  [PDF]
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