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CTRI Number  CTRI/2024/12/078658 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare spinal administration of morphine alone versus morphine with bupivacaine for pain relief during and after surgery in patients undergoing surgeries of liver or gall bladder. 
Scientific Title of Study   To evaluate the effect of addition of Bupivacaine to intrathecal Morphine on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia - a randomised controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Malavika P Nair  
Designation  Post graduate resident 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9746900270  
Fax    
Email  pnairmalavika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandhya K 
Designation  Professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute Super Speciality Hospital, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9972212417  
Fax    
Email  sandyaraghu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandhya K 
Designation  Professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute Super Speciality Hospital, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9972212417  
Fax    
Email  sandyaraghu@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore, Karnataka 560002, India 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute  
Address  Fort, Krishna Rajendra road New Tharaguppett, Kalasipalya Bangalore, Karnataka- 560002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandhya K  Bangalore Medical College and Research Institute   Department of Anaesthesiology, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra road, New Tharaguppett, Bangalore, Karnataka 560002
Bangalore
KARNATAKA 
9972212417

sandyaraghu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intrathecal 0.25mg of morphine alone in patients undergoing hepatobiliary surgeries under general anaesthesia  1 ml of 0.25mg morphine with 1 ml of normal saline will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia 
Intervention  intrathecal 0.25mg of morphine with 0.5% bupivacaine in patients undergoing hepatobiliary surgeries under general anaesthesia  1 ml of 0.25mg morphine with 1 ml of 0.5% bupivacaine will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients belonging to American Society of Anaesthesiologist class I-II, willing to give informed written consent, scheduled to undergo elective hepatobiliary surgeries under general anaesthesia  
 
ExclusionCriteria 
Details  Patients not willing to give consent
Patients undergoing emergency surgeries
Patients having allergy to study drugs
Patients having spinal anomalies or infection, coagulopathy, increased intracranial pressure
Patients belonging to American Society of Anaesthesiologists class III-V
Expected duration of surgery less than 90 min 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics  Time of requirement of first dose of Tramadol 1mg/kg body weight and total opioid requirement in 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess post-operative analgesia using VAS score  To assess the VAS score at 2,4,8,12 and 24 hours post-operatively 
To assess hemodynamic parameters intra-operatively and post-operatively till 24 hours  To assess hemodynamic parameters intra-operatively and at 2,4,8,12,24 hours post-operatively 
To compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough and sedation  To assess the incidence of side effects and their severity based on four point ordinance scale upto 24 hours post-operatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hepatobiliary surgeries are being performed with increasing frequency due to a rising incidence of hepatobiliary diseases. Effectively administered analgesia not only enables greater patient satisfaction by minimising acute postoperative pain, but through alleviating the acute physiological stress response to surgery, it facilitates enhanced recovery outcomes including early mobilisation and return to normal activity, reduced length of hospital stay, and reduced cardiac, respiratory and gastrointestinal postoperative complications leading to improved long-term patient survival rates. Thoracic epidural analgesia is often considered the gold standard analgesic modality in most peri-operative care programmes for patients undergoing hepatobiliary surgeries as it provides required level of analgesia to support mobilization, significant reduction in pulmonary, cardiovascular and thromboembolic morbidity in early post-operative period and reduced requirement of additional opioid analgesia. Despite its popularity, there exists high rates of epidural failure and concerns on its complications especially since epidural is an invasive, high-cost, labour-intensive technique. Furthermore, there is increased risk of epidural hematoma formation - secondary to coagulation changes after hepatobiliary surgeries, even in patients with normal preoperative coagulation profile. Also it is critical to remove the epidural catheter in a timely manner to minimize complications due to post-operative coagulation disturbancesGiven the concerns raised with epidural analgesia in the context of hepatobiliary surgeries, intrathecal anaesthesia has emerged as a promising best practice yielding better patient outcomes as it is a simpler and quicker alternative neuraxial anaesthesia technique, with a lower rate of technical failure. Intrathecal morphine has good analgesic effects with significantly lower failure rates, and other benefits such as decreased postoperative fluid requirements, and shorter postoperative stays. But administration of ITM alone does not adequately prevent the establishment of central sensitization caused by incisional injury—as part of a pre-emptive analgesic strategy, nor assist with low CVP fluid strategies often deployed in these cases. Our hypothesis is that hyperbaric bupivacaine has sufficient cephalad spread to T4, serving as an analgesic bridge prior to the onset of action of intrathecal morphine, thereby lowering opioid requirements intraoperatively and postoperatively. Hence this study aims at prospectively evaluating the potential benefits of the addition of hyperbaric 0.5% bupivacaine to IT morphine 0.25 mg as a spinal regimen for hepatobiliary surgeries done under general anaesthesia.



 
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