Comparison of the effect of two drug patches diclofenac & ketoprofen on pain relief after laparoscopic cholecystectomy operation

Not yet recruiting

• Conditions: 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,

• Registration Number: CTRI/2023/06/053830
• Lead Sponsor: Department of Anaesthesiology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-22
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Post-Graduate Medical Education and Research,Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Post-Graduate Medical Education and Research,Kolkata

🇮🇳Kolkata, WEST BENGAL, India

DR CHANDREYEE SINHA

Principal investigator

9836211379

urfriendcsinha@gmail.com