Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102546768103 Date of Approval: 18/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and Safety of Diclofenac Suppository for Post-operative Pain Relief After Diagnostic Hystero-laparoscopy and Dye Test: A Double-blind Placebo Controlled Randomised Study
Official scientific title Efficacy and Safety of Diclofenac Suppository for Post-operative Pain Relief After Diagnostic Hystero-laparoscopy and Dye Test: A Double-blind Placebo Controlled Randomised Study
Brief summary describing the background and objectives of the trial Diagnostic hystero-laparoscopy and dye test (dHLD) has emerged as the essential tool for the evaluation of female infertility and is the gold standard investigation for tubal patency. Although DHL is performed under general anaesthesia, the pain following the procedures can be enormous. Pain in the postoperative period can result in delayed discharge or prolonged hospital stay following endoscopic procedures with attendant cost implications. This study is aimed at evaluating the efficacy and safety of diclofenac suppository for relieving postoperative pain after diagnostic hystero-laparoscopy and dye test
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 03/12/2020
Actual trial start date 03/12/2020
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diclofenac arm 1oomg Start dose once Individual participant will be administered the content of the envelope (rectal diclofenac or rectal placebo) corresponding the randomly generated code. 54
Control Group Placebo Contains 100 of Ascorbic acid Stat dose Individual participant will be administered the content of the envelope (rectal diclofenac or rectal placebo) corresponding the randomly generated code. 54 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women scheduled for dHLD for infertility at gynaecology clinic of NAUTH and outpatient department of LIFE. 2. Consenting women planned for dHLD without additional procedures. 3. Women between the age of 18 and 45 years. Those women known to have reacted to NSAIDs in the past, those with renal disease/impairment, known asthmatics, gastric or duodenal ulcer and inability to rate pain using visual analogue scale (VAS) Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2020 Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Owerri road Nnewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures will include pain scores at 4th postoperative hour and 2-hourly subsequently up to the 12th postoperative hour using VAS. 4th postoperative hour and 2-hourly subsequently up to the 12th postoperative hour using VAS.
Secondary Outcome The secondary outcome measures will include analgesic requirement, time point when request for first additional analgesic was made, proportion of women requiring additional analgesic agent, patients’ satisfaction, and any adverse event. 4th postoperative hour and 2-hourly subsequently up to the 12th postoperative hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life Specialist Hospital and Nnamdi Azikiwe University Teaching Hospital Ikemba Drive / Owerri road Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Okam Princeston Chukwuemeka Ikemba Drive Nnewi Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Okam Princeston Ikemba Drive Nnewi Nnewi 435101 Nigeria Self funded
COLLABORATORS
Name Street address City Postal code Country
Dr. G.U Eleje Ikemba drive Umuele Umudim, Nnewi Nnewi 435101 Nigeria
Prof. J.I Ikechebelu Ikemba drive, Umuele, Umudim Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Princeston Okam pc.okam@unizik.edu.ng +2348038814711 Ikemba drive Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries George Eleje gu.eleje@unizik.edu.ng +2348068117444 Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Joseph Ikechebelu ji.ikechebelu@unizik.edu.ng +2348034044189 Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be made available. Individual participant data that underlie theresults reported in thisarticle, after deidentification (text,tables, figures, andappendices) will be shared. Data will be available to anyone who wishes to access the data for any purpose immediately following publication, no end date. Data will be made available publicly Informed Consent Form,Study Protocol No end date Data will be available via open access to anyone who wishes to access the data for any purpose immediately following publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information