Home » Trials » SLCTR/2017/013


Effectiveness of Diclofenac Sodium as a pre-emptive analgesic for gynecological laparoscopic surgery: a Randomized Controlled Clinical Trial -

SLCTR Registration Number

SLCTR/2017/013


Date of Registration

20 May 2017

The date of last modification

Jul 27, 2017



Application Summary


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

Post-operative pain


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1194-2407


Any other number(s) assigned to the trial and issuing authority

03/17 (ERC: Sri Jayewardenepura)


Trial Details


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


Assignment

Parallel


Purpose

Prevention


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

  1. Females
  2. Aged between 20 - 65 years
  3. Admitted to the study setting for major and minor laparoscopic gynaecological surgery, under general anaesthesia

Exclusion criteria

  1. Surgical complications such as bowel, bladder or ureter damage
  2. Diagnosed psychiatric illness
  3. Long-term analgesic use
  4. Patients on concomitant medication known to have interactions with NSAIDs
  5. Known allergy or any other contraindication to diclofenac sodium or any other NSAID


Primary outcome(s)

  1. Post-operative pain severity, assessed using a combination of visual analogue scale with Wong-Baker faces.
  2. Need for rescue analgesia

Primary outcome(s) - Time of assessment(s)

  1. At 2 hours, 6 hours and 24 hours post operatively
  2. During the first 24 hours post-operatively

Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Recruiting


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)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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

Contact Person for Public Queries

Dr. Dhammike Silva
Consultant Obstetrician and Gynaecologist
Professorial Gynaecology Unit Colombo South Teaching Hospital Kalubowila, Sri Lanka
Tel: 0112763262




Primary study sponsor/organization

Professorial Gynaecology Unit Colombo South Teaching Hospital

Kalubowila, Sri Lanka
Tel: 011 2 763064


Secondary study sponsor (If any)

None