Home » Trials » SLCTR/2017/013
Effectiveness of Diclofenac Sodium as a pre-emptive analgesic for gynecological laparoscopic surgery: a Randomized Controlled Clinical Trial
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SLCTR Registration Number
SLCTR/2017/013
Date of Registration
The date of last modification
Mar 03, 2019
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 or Health Condition(s) Studied
Post-operative pain
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1194-2407
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
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
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.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Post-operative pain severity, assessed using a combination of visual analogue scale with Wong-Baker faces. |
[ At 2 hours, 6 hours and 24 hours post operatively ] |
|
2.
Need for rescue analgesia |
[ During the first 24 hours post-operatively ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
40 (20 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-06-01
Anticipated end date
2017-09-25
Date of first enrollment
2017-05-24
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-03-23
Approval number
03/17
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Jeewaka Wickramasinghe
Registrar in Obstetrics and Gynecology
Colombo South Teaching Hospital
Kalubowila, Sri Lanka
Tel: 0112763262
Mob: 0772629192
jeewakabw@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
