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.: PACTR202210622254726 Date of Approval: 24/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RECTAL VERSUS INTRAMUSCULAR DICLOFENAC SODIUM FOR PAIN RELIEF AFTER CAESAREAN SECTION: A SINGLE BLIND RANDOMISED CONTROL STUDY
Official scientific title RECTAL VERSUS INTRAMUSCULAR DICLOFENAC SODIUM FOR PAIN RELIEF AFTER CAESAREAN SECTION: A SINGLE BLIND RANDOMISED CONTROL STUDY
Brief summary describing the background and objectives of the trial Background: Caesarean Section is associated with severe pain. Pain Free State is vital for caesarean section patients to cope with care for their babies and also avoid local and systemic complications of pain. Effective pain relief still remains a challenge especially in low resource setting. Aims and Objectives: The aim is to compare the effectiveness of rectal diclofenac sodium and intramuscular diclofenac sodium in reducing pain following caesarean section. Methodology: This will be a single blind randomised control study comparing the effectiveness of rectal diclofenac sodium and intramuscular diclofenac sodium for pain relief in women undergoing elective or emergency lower segment caesarean section under spinal anaesthesia at the Federal Medical Centre, Keffi. However, those excluded will include; pregnant women booked for caesarean delivery under general anaesthesia, those with medical condition known to be potentially exacerbated by non-steroidal anti-inflammatory drugs such as peptic ulcer disease, pregnant women with previous history of adverse reaction or hypersensitivity to diclofenac or pentazocin, those who require special post-operative pain control such as sickle cell disease patient, and those with known renal or liver disease. The blinding will be done by a statistician in conjunction with a pharmacist (both are not part of the study team). The statistician using a computer software randomiser, will generate two sets of random numbers from 1 – 242 in the ratio of 1:1 resulting in 121 participants in each group. These random numbers will serve as labeling for the opaque envelopes that will be used for the drug packaging as well subsequently serve for participant identification number. The pharmacist will do the drug packaging with opaque envelopes. Each sealed, labeled, opaque envelope will contain 3 doses of either of the study drugs wrapped with a piece of bubble wrap, 3 pairs of disposable gloves, three 2ml syringes and 3 prepackaged single-use
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RVID
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 17/10/2022
Actual trial start date
Anticipated date of last follow up 17/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 242
Actual target sample size (number of participants)
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 diclofenac sodium for pain relief after caesarean using intramuscular r rectal route. 75mg of intramuscular diclofenac sodium 12 hourly. 24 hours first dose of 75mg intramuscular diclofenac sodium administered immediately after vulva toileting while participant is still on the operation table and the remaining dose given 12 hourly in the postnatal ward for 24 hours. 121
Control Group diclofenac sodium for pain relief after caesarean section following intramuscular or rectal route. 100mg of suppository diclofenac sodium 12 hourly. 24 hours first dose of 100mg suppository diclofenac inserted into the rectum immediately after vulva toileting while participant is on the operation table, then the remaining dose inserted 12 hourly in the postnatal ward. 121 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Booked participants for elective or emergency lower segment caesarean delivery under spinal anaesthesia. 1. Participants booked for caesarean delivery under general anaesthesia. 2. Participants with medical condition known to be potentially exacerbated by non-steroidal anti-inflammatory drugs such as peptic ulcer disease. 3. Participants with previous history of adverse reaction or hypersensitivity to diclofenac or pentazocin. 4. Participants who require special post-operative pain control such as sickle cell disease patient. 5. Participant with known renal disease. 6. Participants with known liver disease. Adult: 19 Year-44 Year 19 Year(s) 44 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 23/02/2022 FEDERAL MEDICAL CENTRE KEFFI HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ALONG OLD AKWANGA RAD, KEFFI, NASARAWA STATE, NIGERIA KEFFI 961101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the effectiveness of diclofenac sodium for pain relief after caesarean section using rectal or intramuscular route that will be assessed using Visual Analogue Scale (VAS) for pain assessment. 6 hours from the time of administration of the first dose of the study drug, then 6 hourly till 6 hours after the last dose of the study drug.
Secondary Outcome The secondary outcome measures are maternal satisfaction, adverse and side effects of the study drugs. 6 hours from the time of administration of the first dose of the study drug, then 6 hourly till 6 hours after the last dose of the study drug.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE KEFFI NASARAWA STATE KEFFI-AKWANGA ROAD, KEFFI KEFFI 961101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self OBSTETRICS AND GYNAECOLOGY DEPARTMENT, FEDERAL MEDICAL CENTRE KEFFI, NASARAWA STATE KEFFI 961101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR UGWU PAULINUS CHUKWUEMEKA OBSTETRICS AND GYNAECOLOGY DEPARTMENT, FEDERAL MEDICAL CENTRE, KEFFI NASARAWA STATE KEFFI 961101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator UGWU PAULINUS CHUKWEMEKA drdrugwu@gmail.com +2347066705396 OBSTETRIC AND GYNAECOLOGY DEPARTMENT, FEDERAL MEDICAL CENTRE, KEFFI, NASARAWA STATE
City Postal code Country Position/Affiliation
KEFFI 961101 Nigeria SENIOR REGISTRA
Role Name Email Phone Street address
Public Enquiries AKUNEZIRI UCHE ucheakuneziri@gmail.com +2348036302463 QBSTETRIC AND GYNAECOLOGY DEPARTMEANT, FEDERAL MEDICAL CENTRE KEFFI, NASARAWA STATE
City Postal code Country Position/Affiliation
KEFFI 961101 Nigeria CONSULTANT OBSTETRICIAN AND GYNAECOLOGIST
Role Name Email Phone Street address
Scientific Enquiries TUNDEOLATUNJI OLUBUNMI olubunmiolatunji@gmail.com +2348035863359 OBSTETRIC AND GYNAECOLOGY DEPARTMENT, FEDERAL MEDICAL CENTRE, KEFFI, NASARAWA STATE
City Postal code Country Position/Affiliation
KEFFI 961101 Nigeria CONSULTANT OBSTETRICIAN AND GYNAECOLOGIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data generated from the study will be reported using consort trial statement. It will be submitted to West African College of Surgeons and reported in a reputable journal Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 9months Open access
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