| CTRI Number |
CTRI/2026/03/106464 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two pain-relief skin patches after laparoscopic gallbladder surgery |
|
Scientific Title of Study
|
Efficacy of transdermal ketoprofen patch vs diclofenac patch in laparoscopic cholecystectomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Parihar |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9131839659 |
| Fax |
|
| Email |
harshitaparihar7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupam Pandey |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8889480540 |
| Fax |
|
| Email |
docanshu07@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupam Pandey |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Peoples College of Medical Sciences and Research Centre Bhopal |
| Address |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8889480540 |
| Fax |
|
| Email |
docanshu07@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples Hospital Bhopal |
| Address |
Ayodhya Bypass Road Bhanpur Bhopal Madhya Pradesh India 462037 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshita Parihar |
Peoples Hospital |
Room no 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9893666588
harshitaparihar7@gmail.com |
| Harshita Parihar |
Peoples Medical College Bhanpur |
Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal
Madhya Pradesh
462037
India
Bhopal
MADHYA PRADESH |
09893666588
harshitaparihar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College of Medical Sciences And Research Centre By Pass Road Bhopal 462037 M P Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac |
Patients scheduled for elective laparoscopic cholecystectomy will receive a transdermal diclofenac patch of 100 mg transdermal route applied before the surgery whose effect will be observed for 24 hours. |
| Intervention |
Ketoprofen |
Patients scheduled for elective laparoscopic cholecystectomy will receive a transdermal ketoprofen patch of 30 mg through transdermal route applied before the surgery and will be observed for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years of either gender.
ASA grade I and II.
Patients undergoing elective laparoscopic abdominal surgeries.
Patient willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patient refused to participate in the study
Known allergy to NSAIDs
Chronic pain or long term analgesic use
Renal, hepatic or peptic ulcer disease
Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain scores using Visual Analog Scale (VAS) between transdermal ketoprofen patch and diclofenac patch following laparoscopic cholecystectomy for 6 months (24 weeks). |
To compare postoperative pain scores using Visual Analog Scale (VAS) between transdermal ketoprofen patch and diclofenac patch following laparoscopic cholecystectomy for 6 months (24 weeks ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first rescue analgesic requirement and the total postoperative opioid/analgesic consumption within the first 24 hours |
upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
After ethical approval and informed consent, adult ASA I-II patients will be scheduled for elective laparoscopic cholecyctectomy will be randomly allocated into two groups. Group K will receive a transdermal ketoprofen patch and Group D a transdermal diclofenac patch applied before the surgery. All patients will undergo standardized general anesthesia. Postoperative pain will be assessed using VAS at predetermined intervals for 24 hours. Rescue analgesia will be given as required and recorded. Data will be analyzed to compare pain scores. |