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.: PACTR202103495385214 Date of Approval: 29/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rectal versus Oral Diclofenac for Relief of Perineal Pain after Episiotomy Repair: A Randomized Controlled Single-blind (Outcome Assessors) Study
Official scientific title Rectal versus Oral Diclofenac for Relief of Perineal Pain after Episiotomy Repair: A Randomized Controlled Single-blind (Outcome Assessors) Study
Brief summary describing the background and objectives of the trial Background Episiotomy is a surgical procedure that involves incision of the perineum in the second stage of labour to facilitate vaginal delivery. Perineal pain from tear or episiotomy is a common problem after vaginal delivery. The provision of safe and effective pain relief for perineal trauma using rectal analgesia is one of several therapies used in clinical practice, which also include oral analgesics, local anaesthetics, therapeutic ultrasound, and non-pharmacological applications such as baths and ice packs. Evidence of the efficacy and safety of rectal analgesia is limited. Objectives The study will be performed to compare the efficacy of rectal and oral diclofenac following the repair of episiotomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPIANALGESIA TRIAL
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 30/11/2021
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 176
Recruitment status Not yet 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rectal diclofenac 100mg Every 12 hours for 24 hours The rectal diclofenac will be removed from the opaque sealed envelope and one tablet of 100mg gently inserted digitally into the rectum after immediate completion of perineorrhaphy while the remaining two will be kept by the patient bedside to be repeated 12 hourly by the same doctor or another doctor on call. 88
Control Group Oral diclofenac 100mg Every 12 hours for 24 hours. The nurse-midwife on duty will dispense one tablet of 100mg diclofenac out of the three within a drug envelope immediately after perineal repair to the participant to take with some sips of water while the remaining two tablets will be kept by her bedside to be repeated at 12 hourly period by same nurse or another nurse on next shift. 88 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Parturient with uncomplicated singleton pregnancy at term who will have episiotomy at delivery. 1. Perineal tear other than episiotomy. 2. major postpartum haemorrhage. 3. History of NSAID allergy, gastric or duodenal ulcer, hepatic disease, renal disease, asthma, coagulopathy. 4. Any patient that will require special post-delivery pain control such as sickle cell disease patient and those who decline to be part of the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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
No 17/03/2021 Federal Medical Center Lokoja Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
No 1, Saliu Ibrahim Way Lokoja 270001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. mean pain scores. 2. mean time interval between the first dose of both rectal or oral diclofenac and patient’s first demand for additional analgesia. At 0, 1, 4, 8, 16 and 24 hours and at demand for rescue analgesic using the numeric rating pain scale.
Secondary Outcome 1. Proportion of women with side effects 2. Maternal satisfaction following rectal and oral diclofenac measured by Likert scale. 24hours after perineorrhaphy.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Federal Medical Center Lokoja No 1, Saliu Ibrahim Way Lokoja 270001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Investigators No 1, Saliu Ibrahim Way Lokoja 270001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Ifeagwu Chika Sampson Phase II Estate, Lokongoma Lokoja 270001 Nigeria Individual
Secondary Sponsor Dr. Adewole Adebayo Alade Sam Akoji Crescent, Phase II, Lokongoma Lokoja 270001 Nigeria Individual
Secondary Sponsor Dr. Nzurumike Charles Nnanna Saliu Ibrahim Way Lokoja 270001 Nigeria Individual
Secondary Sponsor Dr. Musa Abdulkarim Omoyine Opposite Ostrich Bakery, Ganaja Junction Lokoja 270001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Adewole Adebayo Alade Sam Akoji Crescent, Phase II Lokongoma Lokoja 270001 Nigeria
Nzurumike Charles Nnanna Saliu Ibrahim Way Lokoja 270001 Nigeria
Musa Abdulkarim Omoyine Opposite Ostrich Bakery Ganaja Junction Lokoja 270001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chika Ifeagwu scotoifeagwu@yahoo.com +2348036694972 Phase II Estate, Lokongoma
City Postal code Country Position/Affiliation
Lokoja 270001 Nigeria Senior registrar Department of OBGYN Federal Medical Center Lokoja Nigeria
Role Name Email Phone Street address
Public Enquiries Adebayo Adewole adewoleobsgyn@hotmail.com +2348036324806 Sam Akoji Crescent
City Postal code Country Position/Affiliation
Lokoja 270001 Nigeria Consultant OBGYN Dept. of OBGYN Federal Medical Center Lokoja Nigeria.
Role Name Email Phone Street address
Public Enquiries Chika Ifeagwu scotoifeagwu@yahoo.com +2348036694972 Phase II Estate, Lokongoma
City Postal code Country Position/Affiliation
Lokoja 270001 Nigeria Senior Registrar Department of OBGYN Federal Medical Center Lokoja Nigeria
Role Name Email Phone Street address
Scientific Enquiries Adebayo Adewole adewoleobsgyn@hotmail.com +2348036324806 Sam Akoji Crescent, Phase II Estate, Lokongoma, Lokoja, Kogi State, Nigeria.
City Postal code Country Position/Affiliation
Lokoja 270001 Nigeria Consultant Infertility and Minimal Access Unit Dept of OBGYN Federal Medical Center Lokoja Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participants Data will be shared. Informed Consent Form,Study Protocol IPD will be shared within 6 months of the completion of the study. Scientific community interested in the IPD
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