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.: PACTR202407781417769 Date of Approval: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pentazocine-Suppository Paracetamol Versus Pentazocine-Suppository Diclofenac for Post-Caesarean Section Pain Relief: A Randomized Controlled Trial
Official scientific title Pentazocine-Suppository Paracetamol Versus Pentazocine-Suppository Diclofenac for Post-Caesarean Section Pain Relief: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial BACKGROUND: One of the most prevalent procedures in obstetrics is the Caesarean section (CS), and good pain management following the procedure promotes early mobility, early mother-child attachment, increased patient satisfaction, and improved maternal outcomes. The therapy of pain following a Caesarean section has been demonstrated to benefit from a multimodal strategy rather than a unimodal one. However, the most effective combination and mode of administration have to be determined. Routes of administration of analgesics have not been adequately explored. Rectal administration is favorable because medicine absorbed by the rectum bypass the liver and avoids the hepatic first-pass metabolism associated with oral consumption. This suggests that the rectal route is more efficient for local activities and may offer quicker pain alleviation. Recommendations have been made to implement administration methods that are safer and more patient-friendly, aiming to reduce the occurrence of injection cellulitis, anaphylactic reactions, and injection abscesses. It has been discovered that the rectal mode of administration maintains analgesic effectiveness while minimizing potential risks and it offers the advantage of being administered by junior staff members, thereby requiring less training unlike the safe administration of injectables The Aim is to compare the efficacy of suppository paracetamol with suppository diclofenac as supplemental analgesic to parenteral pentazocine in post-Caesarean section pain relief. The Objectives include (1) To determine VAS pain scores at 6, 12, 18 and 24 hours following the use of either pentazocine-paracetamol suppository or pentazocine-diclofenac Suppository after caesarean section. (2) To compare post-caesarean section pain and incidence of adverse effects between the two study groups. (3) To compare patient’s satisfaction with analgesia in both study groups
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 Post-Caesarean section pain relief.
Purpose of the trial Education /Training
Anticipated trial start date 16/09/2024
Actual trial start date
Anticipated date of last follow up 14/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 288
Actual target sample size (number of participants)
Recruitment status Active, not 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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A A dosage of 1000mg of scheduled rectal paracetamol and 30mg of intravenous pentazocine every 6 hours 24 hours All participants will receive regional (spinal) anesthesia at surgery, using 0.5% hyperbaric (heavy) bupivacaine intrathecally. 30 mg of pentazocine shall be given intravenously to all subjects within ten minutes of completion of surgery in the operating room (time zero). These shall be repeated at intervals of 6 hours for 24 hours. 144 participants shall be given the first dose of the 1000mg of paracetamol suppository immediately after vulval toileting before they are wheeled out of the operating room. This will be repeated at intervals of 6 hours for 24 hours. In case of breakthrough pain, 30mg of pentazocine will be given 144
Control Group Group B A dosage of 50 mg of scheduled rectal diclofenac and 30mg of intravenous pentazocine every 6 hours 24 hours All participants will receive regional (spinal) anesthesia at surgery, using 0.5% hyperbaric (heavy) bupivacaine intrathecally. 30 mg of pentazocine shall be given intravenously to all subjects within ten minutes of completion of surgery in the operating room (time zero). These shall be repeated at intervals of 6 hours for 24 hours. 144 participants shall be given the first dose of the 50mg of diclofenac suppository immediately after vulval toileting before they are wheeled out of the operating room. This will be repeated at intervals of 6 hours for 24 hours. In case of breakthrough pain, 30mg of pentazocine will be given 144 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting parturient aged 18 years and above scheduled for elective or emergency Caesarean section under regional anesthesia 1. History of peptic ulcer disease 2. Patients who had Caesarean delivery under general anesthesia 3. History of hypersensitivity reaction to pentazocine, paracetamol or diclofenac 4. Severe Pre-eclampsia/Eclampsia 5. Renal and hepatic dysfunction 6. Patients who develop postoperative complications such as PPH 7. Any patient that will require special post-delivery pain control, such as sickle cell disease patients 8. Unconscious patient (GCS <=7) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 05/05/2024 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5, OBA AKINJOBI WAY, IKEJA, LAGOS 101233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The visual analogue pain score will be used to quantify post-operative pain management as the primary end measure outcome will be measured at 6hour, 12hour, 18hour and 24hour post-interventions following caesarean section
Secondary Outcome patient satisfaction, the length of time an analgesic medication relieves pain, the need for rescue analgesia and unfavorable outcomes for mothers. 24hour post-intervention following caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5, OBA AKINJOBI WAY IKEJA LAGOS 101233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
IMODUPEOLA IBRAHIM 21, OGUNGBADE STREET, OPEKI ROAD IPAJA LAGOS 100278 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MODUPEOLA IBRAHIM 21, OGUNGBADE STREET, OPEKI ROAD IPAJA LAGOS 100278 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MODUPEOLA IBRAHIM sadikk101@yahoo.com +2348034254134 21, OGUNGBADE STREET, OPEKI ROAD
City Postal code Country Position/Affiliation
IPAJA LAGOS 100278 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries JOY CHIONUMA agbara.joy2012@gmail.com +2348028350052 1-5, OBA AKINJOBI WAY
City Postal code Country Position/Affiliation
IKEJA LAGOS 101233 Nigeria SUPERVISING CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries ABIDOYE GBADEGESIN abidoyegbadegesin@gmail.com +2348023039807 1-5, OBA AKINJOBI WAY
City Postal code Country Position/Affiliation
IKEJA LAGOS 101233 Nigeria SUPERVISING CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study may be made available to qualified researchers who have a scholarly interest in Obstetrics' analgesia. PHI won't be included in the exchanged data. Before exchanging data with the asking party, the request must be approved, and any relevant contracts (such as a material transfer agreement) must be signed Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data can be requested starting from 9 months after an item is published and it will be available for up to 24 months. Extensions will be evaluated on an individual basis. Qualified researchers doing scientific research may seek access to trial IPD: access will be granted following assessment and approval of a study proposal, statistical analysis plan (SAP), and execution of a data sharing agreement (DSA). For more information, please contact sadikk101@yahoo.com
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