SLCTR Registration Number
Date of Registration
The date of last modification
Jul 27, 2017
Scientific Title of Trial
Effectiveness of Diclofenac Sodium as a pre-emptive analgesic for gynecological laparoscopic surgery: a Randomized Controlled Clinical Trial
Public Title of Trial
Effectiveness of painkillers given before surgery to minimize post-surgical pain
Disease of Health Condition(s) Studied
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
03/17 (ERC: Sri Jayewardenepura)
What is the research question being addressed?
What is the effectiveness of diclofenac sodium suppositories in pain relief when given pre-emptively as opposed to post-operatively in women undergoing gynaecological laparoscopic surgeries?
Type of study
Randomized controlled trial
The study will be carried out at ward 23, Colombo South Teaching Hospital (CSTH).
Participants meeting the inclusion/exclusion criteria will be allocated to the study arms using computer generated random numbers.
Arm A (intervention arm) will receive a single rectal administration of diclofenac sodium 100mg (suppository) 30 minutes prior to the procedure. A single rectal administration of an identical matching placebo (suppository) will be given immediate post-operatively.
Arm B (control arm) will receive a single rectal administration of the placebo (suppository) 30 minutes prior to the procedure. A single rectal administration of diclofenac sodium 100mg (suppository) will be given immediate post-operatively.
Standard of care: All patients will be receive general anesthesia and will be given the standard weight calculated doses of same IV pain relief preparations during the surgery. If any of the subjects of either group develop pain they will be adequately provided with postoperative analgesia according to standard unit protocols (IV pethidine, IV / oral tramadol or diclofenac sodium suppositories).
Patients and outcome assessors will be blinded to the intervention status.
Primary outcome(s) - Time of assessment(s)
Secondary outcome(s) - Time of assessment(s)
Target number/sample size
40 (20 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayewardenepura on 23rd March 2017 (Ref 03/17)
None (Investigator funded)
Contact person for Scientific Queries/Principal Investigator
Dr. Jeewaka Wickramasinghe
Registrar in Obstetrics and Gynecology
Colombo South Teaching Hospital Kalubowila, Sri Lanka