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.: PACTR202404650060916 Date of Approval: 17/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post Caesarean Section Analgesia: A Comparative Study of Double Versus Triple Drug Combinations for Post Caesarean Section Analgesia at the Federal Medical Centre, Abuja- A Triple Blind Randomized Controlled Study.
Official scientific title Post Caesarean Section Analgesia: A Comparative Study of Double Versus Triple Drug Combinations for Post Caesarean Section Analgesia at the Federal Medical Centre, Abuja- A Triple Blind Randomized Controlled Study.
Brief summary describing the background and objectives of the trial Background: Pain is a recognized serious public health problem. Postoperative pain is a common complication following a caesarean section and its inadequate management contribute contributes significantly to maternal morbidity and even mortality. Aim: The aim of this study is to compare the effectiveness of two regimens involving double (Pentazocine and Diclofenac) versus triple (Pentazocine, Diclofenac, and Paracetamol) drug combinations for post–caesarean section pain relief. Setting: The Maternity Unit of the Department of Obstetrics and Gynaecology of the Federal Medical Centre, Abuja. Methodology: This study will be a triple-blind randomized controlled study. A total of 234 eligible clients who meet the inclusion criteria will be recruited for the study and randomized into two groups (A or group B) using a computer-generated random numbers. Group A will be the control group and will receive intramuscular pentazocine 0.5mg/kg 6hourly, suppository diclofenac 100mg 12hourly and an intravenous placebo of 6mls of sterile water 8hourly for 48hours, while group B will be the treatment group and will receive intramuscular pentazocine 0.5mg/kg 6hourly, suppository diclofenac 100mg 12hourly and intravenous paracetamol 900mg 8hourly for 48hours. The primary outcome measure will be control of postoperative pain which will be assessed using the visual analogue scale, while the secondary outcome measures will be patient satisfaction, need for rescue analgesia, maternal side effects, and time for commencement of ambulation and breastfeeding. All information obtained will be recorded on a data collection sheet designed for the study. Results: The collected data will be coded and entered into a computer software package and analyzed using a statistical package for social sciences (SPSS) version 28.0.1.1. The results of the analysis will be presented using suitable tables.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2024
Actual trial start date 09/02/2024
Anticipated date of last follow up 10/06/2024
Actual Last follow-up date 14/06/2024
Anticipated target sample size (number of participants) 234
Actual target sample size (number of participants) 234
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FMCABJHREC2023089 HREC, FMC, ABUJA
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Acetaminophen IV Acetaminophen 900mg 8 hourly 48 Hours Acetaminophen is an analgesic and antipyretic medication with a weak anti-inflammatory property. Its mechanism of action remains unknown but it is thought to act in the central and peripheral nervous systems by inhibiting the enzyme cyclooxygenase (COX) which converts arachidonic acid (a fatty acid) to prostaglandins. Acetaminophen reduces pain by the above mechanism. It acts more centrally than peripherally as compared to NSAIDS by inhibiting a form of COX known as COX-3 and so will relieve pains by acting more via the central route. It can be used in moderate to severe pains like postoperative pains. The usual dose is 600 -1000mg given either intravenously or intramuscularly 6 hourly. It may cause hepatocellular damage and renal tubular necrosis at certain doses. It is safer than the NSAIDs, especially in individuals with peptic ulcer disease. 117
Control Group Sterile water 9mls 48hours Sterile water 9mls 8hourly 117 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged ≥ 18 years who are booked for, and have given consent, for elective or emergency caesarean section procedure under spinal anaesthesia at term in the hospital. . Refusal to give consent 2. History of opioid dependency 3. Cardio-pulmonary depression 4. History of chronic kidney or liver disease 5. Known allergy to pentazocine, diclofenac and acetaminophen 6. Delirium 7. General anaesthesia 8. Prematurity 9. Intra uterine fetal death 10. Prolonged surgery greater than 2 hours 12. Sickle cell disease 13. Any adverse fetomaternal outcome e.g. ICU or NICU admission. 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 12/07/2023 HREC FMC ABUJA
Ethics Committee Address
Street address City Postal code Country
ABUJA Abuja PMB 7011 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean pain scores 1, 12,24,36 and 48th hours post caesarean section
Secondary Outcome Maternal satisfaction, presence/absence of maternal side effects, time taken for the commencement of ambulation, and breastfeeding. 1, 12, 24,36 and 48th Hours post caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE ABUJA JABI ABUJA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical residency training fund FMC Abuja abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor FGN FMC ABUJA ABUJA Nigeria Government
COLLABORATORS
Name Street address City Postal code Country
DR EKWEANI JOHN FMC ABUJA ABUJA Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator UGOCHUKWU OKOLI tombeanyi@gmail.com 08062203595 jabi abuja
City Postal code Country Position/Affiliation
abuja Nigeria senior registrar
Role Name Email Phone Street address
Public Enquiries Jegede Peter hrec.fmcabj@gmail.com 08037779155 FMC ABUJA
City Postal code Country Position/Affiliation
ABUJA Nigeria Secretary HREC
Role Name Email Phone Street address
Scientific Enquiries JOHN EKWEANI johananie@gmail.com 08034517847 fmc abuja
City Postal code Country Position/Affiliation
Abuja Nigeria supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data, also known as raw data, will be shared and published within 12 months of the completion of the study. Informed Consent Form,Study Protocol 12 months after completion of the study Abstracting and indexing
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