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CTRI Number  CTRI/2025/11/096974 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find which method gives better pain relief in patients undergoing liver,gall bladder and pancreas surgery — a single pain injection near the spinal cord or continuous pain medicine through a small tube placed around the spinal nerves(epidural space).”  
Scientific Title of Study   Comparative study of intrathecal morphine versus thoracic epidural for post operative analgesia in patients undergoing hepato pancreato biliary surgery : A Randomised Control Trial 
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 Santosh 
Designation  Junior Resident 
Affiliation  AIIMS Patna  
Address  B5B OT Complex, 5th floor, IPD building, AIIMS Patna, Phulwari Shariff, Patna, Bihar

Patna
BIHAR
801507
India 
Phone  8105076731  
Fax    
Email  santosh15m3321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shagufta Naaz 
Designation  Additional Professor 
Affiliation  AIIMS Patna  
Address  Room no. 501, B5B OT Complex, 5th floor, IPD building, AIIMS Patna, Phulwari Shariff, Patna

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh 
Designation  Junior Resident 
Affiliation  AIIMS Patna  
Address  B5B OT Complex, 5th floor, IPD building, AIIMS Patna, Phulwari Shariff, Patna, Bihar

Patna
BIHAR
801507
India 
Phone  8105076731  
Fax    
Email  santosh15m3321@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, 5th floor IPD AIIMS Patna, Bihar 801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  Department of Anesthesiology IPD 5th floor AIIMS Patna Bihar 801507  
Type of Sponsor  Research institution and hospital 
 
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 Santosh  AIIMS Patna   Department of Anesthesiology 5th floor IPD building AIIMS Patna, Bihar, Patna
Patna
BIHAR 		 8105076731

santosh15m3321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIIMS Patna  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 
Intervention  Single shot intrathecal morphine  Patients in this group will receive intrathecal injection of morphine before induction at L3-L4 or L4-L5 space using a dose of 5micrograms/kg as 0.5ml plus 2ml of 0.5% of Heavy bupivacaine(total volume of 2.5ml) administered into the subarachanoid space 
Comparator Agent  Thoracic epidural  Patients in this group will receive thoracic epidural analgesia using 0.125% bupivacaine with 40micrograms of morphine(in a total volume of 6ml) administered via the epidural catheter before surgical incision after induction. Infusion of 0.125% Bupivacaine at a rate of 5ml/hour via the epidural catheter will be started intra-operatively and continued post operatively for a period of 48 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing Elective hepato-pancreato-biliary surgery
American Society of Anaesthesiologists status I, II, III.
BMI – 18-24kg/m2
 
 
ExclusionCriteria 
Details  1. Patients with contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at injection site, severe spine deformity, known allergy or
hypersensitivity).
2. Chronic opioid use or opioid dependence prior to surgery.
3. Patients who couldn’t understand the technique of operating the PCA pump
4. Patients who are not extubated within 48hours after surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate total opioid consumption over 48 hours postoperatively in adult patients undergoing hepatopancreatobiliary surgeries, comparing those receiving intrathecal morphine with those receiving thoracic epidural analgesia.  Total opioid consumption after 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the incidence of analgesia-related complications such as hypotension, vomiting, respiratory depression among both groups
 		 Within first 7 days after surgery 
To assess time to first rescue analgesia among both groups
 		 In the post operative period  
To compare peri-operative fluid use among both groups
 		 Within the first 48 hours of surgery 
To compare the length of hospital stay among both groups  Till the patient is discharged from the hospital 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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   Phase 4 
Date of First Enrollment (India)   25/11/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [santosh15m3321@gmail.com].

  6. For how long will this data be available start date provided 02-11-2025 and end date provided 02-02-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study aims to compare two common methods of pain relief—intrathecal morphine and thoracic epidural analgesia—in patients recovering from hepato-pancreato-biliary (HPB) surgery. Eighty-eight adult patients will be randomly assigned to receive either a single injection of intrathecal morphine or a continuous thoracic epidural infusion for postoperative pain control. The main focus is to measure total opioid use in the first 48 hours after surgery, along with side effects, time to additional pain relief, fluid needs, and hospital stay. The goal is to find out whether intrathecal morphine can provide pain relief that is just as effective and safe as the epidural method, while being simpler to use and more comfortable for patients during their recovery.

 
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