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CTRI Number  CTRI/2025/02/080666 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
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 drug morphine versus fentanyl for pain relief during and after surgery in patients undergoing surgeries of liver or gall bladder. 
Scientific Title of Study   To compare the efficacy and safety of intrathecal Morphine and Fentanyl on intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia 
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 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 Tharaguppettu, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9972212417  
Fax    
Email  sandyaraghu@gmail.com  
 
Details of Contact Person
Scientific Query
 
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 Tharaguppettu, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9746900270  
Fax    
Email  pnairmalavika@gmail.com  
 
Details of Contact Person
Public Query
 
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 Tharaguppettu, Bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9746900270  
Fax    
Email  pnairmalavika@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, 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: K70-K77||Diseases of liver, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intrathecal 0.025mg of fentanyl in patients undergoing hepatobiliary surgeries under general anaesthesia  1 ml of 0.025mg fentanyl diluted to 2 ml will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia and patient will be followed up till 24 hours for assessing post-operative pain, requirement of rescue analgesics and associated side effects 
Intervention  Intrathecal 0.25mg of morphine in patients undergoing hepatobiliary surgeries under general anaesthesia   1 ml of 0.25mg morphine diluted to 2 ml will be administered intrathecally for intra-operative and post-operative analgesia in patients undergoing hepatobiliary surgeries under general anaesthesia and patient will be followed up till 24 hours for assessing post-operative pain, requirement of rescue analgesics and associated side effects 
 
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
 
To measure and compare the two groups based on requirement of intra-operative and post-operative rescue analgesics at 2nd, 4th, 8th, 12th and 24th hour following surgery.
 
 
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 compare the incidence of side effects such as hypotension, nausea, vomiting, pruritus, cough, respiratory depression 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)   27/02/2025 
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="0"
Months="4"
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 more frequently performed nowadays due to a rising incidence of hepatobiliary diseases. Effectively administered analgesia enables greater patient satisfaction by minimising acute postoperative pain, alleviates the acute physiological stress response to surgery, and 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 considered the gold standard analgesic modality for patients undergoing hepatobiliary surgeries as it provides adequate analgesia to support mobilization, with significant reduction in pulmonary, cardiovascular and thromboembolic morbidity in early post-operative period and reduced requirement of additional opioid analgesia. However , there exists high rates of epidural failure and  complications especially since it is an invasive, high-cost, labour-intensive technique. Also , there is increased risk of epidural hematoma formation  due to coagulation abnormalities after hepatobiliary surgeries, even in patients with normal preoperative coagulation profile. Furthermore,  the epidural catheter should be removed in a timely manner to minimize complications due to post-operative coagulation disturbancesIn view of the concerns raised with epidural analgesia in hepatobiliary surgeries, intrathecal anaesthesia has emerged as a promising simpler and quicker alternative technique, yielding better patient outcomes with a lower rate of technical failureFentanyl is a phenyl piperidine derivative, synthetic opioid agonist which is more potent, more lipid soluble with faster onset of action and relatively shorter duration of action. Morphine is a hydrophilic phenanthrene derivative with comparatively slower onset of action and a significantly longer duration of action. However, it has the potential to cause adverse effects, especially delayed respiratory depression and hence requires more vigilant protocolHence this study aims at comparing the efficacy and safety of intrathecal morphine and fentanyl in hepatobiliary surgeries under GA , in terms of intraoperative and post operative analgesia, requirement of rescue analgesics and potential side effects.

 
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