| CTRI Number |
CTRI/2023/06/053830 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of two drug patches diclofenac & ketoprofen on pain relief after laparoscopic cholecystectomy operation |
|
Scientific Title of Study
|
A comparative evaluation of transdermal diclofenac patch versus transdermal ketoprofen patch for post-operative analgesia in laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR CHANDREYEE SINHA |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Department of Anaesthesiology, IPGME&R
244,AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9836211379 |
| Fax |
|
| Email |
urfriendcsinha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHIRANJIB BHATTACHARYYA |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Department of Anesthesiology,
Main O.T Complex
IPGME&R
244,AJC Bose Road, Kolkata- 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHIRANJIB BHATTACHARYYA |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Department of Anaesthesiology,
Main O.T Complex
IPGME&R
244,AJC Bose Road, Kolkata- 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research ,Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post-Graduate Medical Education and Research,
244 AJC Bose Road Kolkata-700020 |
| Type of Sponsor |
Government 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 CHANDREYEE SINHA |
Institute of Post-Graduate Medical Education and Research,Kolkata |
Department of Anaesthesiology,Main Block,IPGME&R,244,AJC Bose Rod,Kolkata-700020
Kolkata
WEST BENGAL |
9836211379
urfriendcsinha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transadermal Diclofenac patch |
Comparison of the efficacy and safety of transdermal ketoprofen patch(30 mg)and transdermal diclofenac patch(100mg)studied 2hr, 4hr, 6hr and 12hr post-operatively in laparoscopic cholecystectomy patients upto first 12 hrs after surgery. |
| Intervention |
Transdermal Ketoprofen patch |
Comparison of the efficacy and safety of transdermal ketoprofen patch(30 mg)and transdermal diclofenac patch(100mg)studied 2hr, 4hr, 6hr and 12hr post-operatively in laparoscopic cholecystectomy patients upto first 12 hrs after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18 to 60 years.
2)Posted for laparoscopic cholecystectomy under general anaesthesia
3)Belonging to ASA physical status 1 and 2.
4)Weight between 40 to 80 kgs.
5)Duration of surgery approximately 60-90 minutes.
|
|
| ExclusionCriteria |
| Details |
1)Patient with significant cardiovascular,renal, hepatic,neurological disease.
2)Known allergy to study drugs.
3)Chronic use of opioids /anti-inflammatory drugs
4)Patients in whom laparoscopic surgery was converted to open procedure
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to administration of first dose of rescue analgesia in patient receiving ketoprofen and diclofenac skin patches |
Post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Total duration of rescue analgesic in the first 12 hours of the surgery.
2)Incidence of systemic side effects like nausea,vomiting, gastritis, sedation, dizziness etc.
3)Incidence of local dermal side effects like pruritus, erythema, dermatitis ,etc.
|
Post operative period |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
22/06/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study a comparison will be made between the efficacy and safety of transdermal diclofenac(100 mg) skin patch and transdermal ketoprofen(30 mg) skin patch in terms of time to administration of the first dose of rescue analgesia, total dose of rescue analgesic in the first 12 hours after surgery and incidence of adverse effects in patients undergoing laparoscopic cholecystectomy surgery in the post-operative period. |