| CTRI Number |
CTRI/2026/02/104298 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparision of two differant dose of Morphine in epidural anesthesia for post operative pain relief in abdominal surgery |
|
Scientific Title of Study
|
Dose-Response Study of Epidural Morphine for Postoperative Analgesia in Thoraco-abdominal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KINJAL SANGHVI |
| Designation |
PROFESSOR |
| Affiliation |
GCS Medical College and Research Centre |
| Address |
GCSMC
anesthesia department ground floor
narodaroad
Ahmedabad
GCSMC
Anesthesia department
10 TH floor
naroda road
Ahmedabad
Gandhinagar
GUJARAT
380025
India |
| Phone |
9924564422 |
| Fax |
|
| Email |
sanghvidrkinjal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KINJAL SANGHVI |
| Designation |
PROFESSOR |
| Affiliation |
GCS Medical College and Research Centre |
| Address |
Anesthesia department
ground floor
GCSMC
narodaroad
Ahmedabad
Anesthesia department
10th floor
GCSMC
narodaroad
Ahmedabad
Gandhinagar
GUJARAT
380007
India |
| Phone |
9924564422 |
| Fax |
|
| Email |
sanghvidrkinjal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KINJAL SANGHVI |
| Designation |
PROFESSOR |
| Affiliation |
GCS Medical College and Research Centre |
| Address |
Anesthesia department
ground floor
GCSMC
narodaroad
Ahmedabad
Anesthesia department
ground floor
GCSMC
narodaroad
Ahmedabad
Gandhinagar
GUJARAT
380007
India |
| Phone |
9924564422 |
| Fax |
|
| Email |
sanghvidrkinjal@gmail.com |
|
|
Source of Monetary or Material Support
|
| gcsmc anesthesia department ground floor |
|
|
Primary Sponsor
|
| Name |
gcsmc hospital |
| Address |
Anesthesia department
ground floor
GCSMC
narodaroad
Ahmedabad
380025
INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kinjal Sanghvi |
GCS Hospital |
Ground floor RM NO 102
OT complex 1, GCS Hospital,Chamunda bridge, Opp. DRMoffice, Naroda
Ahmadabad
GUJARAT |
9924564422
sanghvidrkinjal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE Biomedical and health research EC/NEW/INST/2021/GJ/0009 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: C17||Malignant neoplasm of small intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
epidural morphine |
grp 1 1.5 mg epidural morphine
grp 2 3 mg epidural morphine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 to ASA grade 3
elective surgery
thoraco abdominal surgery under General Anesthesia |
|
| ExclusionCriteria |
| Details |
ASA grade 4 andASA grade 5
not giving consent
coagulation abnormality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS score
Time for first resque analgesic
total opoid consumption |
VAS score within 24 hrs
Time for first resque analgesic
total opoid consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MODIFIED RAMSAYSEDATION SCORE
HEMODYNAMIC DATA |
48 HRS |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
WE WILL ACESS THE QUALITY OF POSTOPERATIVE ANALGESIA WITH EPIDURAL MORPHINE ANY SIDE EFFECTS OR COMPLICATION |