| CTRI Number |
CTRI/2023/06/053411 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| 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
|
comparison of result of pain reduce capability transdermal diclofenac patches
versus transdermal ketoprofen patch after operation
diagnostic gynaecological laparoscopy. |
|
Scientific Title of Study
|
Evaluation of efficacy of transdermal diclofenac patch
versus transdermal ketoprofen patch for post operative
analgesia in diagnostic gynaecological laparoscopy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanmoy Sarkar |
| Designation |
PGT |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of anesthesiology ipgmer
244,ajc Bose road kolkata-20
Department of anaesthesiology, ipgmer 244,AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
08768009750 |
| Fax |
|
| Email |
www.tant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of anaesthesiology ipgmer 244,ajc bose road kolkata 20
Department of anaesthesilogy ipgmer 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 |
PGT |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Department of anaesthesiology ipgmer 244,ajc Bose road Kolkata 20
Department of anaesthesiology ipgmer 244,AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
09433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology ipgmer 244 ajc bose road kolkata 20 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Institute of post graduate medical education and research |
| Address |
Department of anaesthesiology
Ipgmer,244,ajc Bose road kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR CHIRANJIB BHATTACHARYYA |
IPGME&R 244 AJC Bose road ;KOLKATA-700020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTanmoy Sarkar |
Gynaecology OT , IPGME&R,SSKM Hospital,Kolkata. |
Department of obstetric and genecology ipgmer 244, AJC Bose road, kolkata-700020
Kolkata
WEST BENGAL |
08768009750
www.tant@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac transdermal patch |
Compare the analgesic efficacy and safety profile of
ketoprofen patch with diclofenac patch for 12 hours post operative in patient
undergoing laparoscopic gynaecology under general
anaesthesia less than 1 hour |
| Intervention |
ketoprofen transdermal patch |
The analgesic efficacy and safety profile of transdermal
ketoprofen patch for post operative analgesia for 12 hours post operative
in patients undergoing gynaecological laparoscopy under general anaesthesia less than 1hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Posted for elective diagnostic gynaecological laparoscopic surgery under general anaesthesia
Belonging to ASA physical status 1 and 2.
Weight between 40 to 80 kgs.
Duration of surgery upto 60 mints. |
|
| ExclusionCriteria |
| Details |
Patient with significant cardiovascular,renal,hepatic,neurological disease.
Known allergy to study drugs.
Patients who received opioid/non opioid analgesic upto 1week before surgery.
Pregnant and lactating mothers.
If surgery was converted to open laparotomy. |
|
|
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 |
To compare the time to
administration of rescue analgesia in patient receiving
ketoprofen & diclofenac skin patches. |
post extubation |
|
|
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,vomitimg,gastritis,etc.
3)Incidence of local side effects like
pruritus,erythema, dermatitis ,etc. |
post extubation |
|
|
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)
|
10/06/2023 |
| 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
|
The analgesic efficacy and safety profile of transdermal ketoprofen patch has not been compared with transdermal diclofenac patch for post operative analgesia in patients undergoing gynaecological laparoscopy under general anaesthesia. The study is relevant because it intends to address these unexplored issues. It is expected that, based on published literature, ketoprofen patch is better in safety and efficacy than diclofenac patch in gynaecological laparoscopy under general anaesthesia |