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.: PACTR202402498343563 Date of Approval: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pain Management after Caesarean Delivery
Official scientific title Effectiveness of Intravenous Vitamin C as an Adjuvant to Rectal Diclofenac and Intravenous Paracetamol in Pain Management after Caesarean Delivery: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Post-operative pain management has remained one of the daunting challenges facing both surgeons and patients as complaints of unrelieved pain remain a source of concern following surgery. Usually described as severe, especially within the first twenty-four hours after surgery, post-operative pain can be distressing and with possible psychological impact on the patient. Vitamin C as an adjuvant has been used with positive results in the management of various kinds of pain such as post-operative pain, post-herpetic pain, and chronic pain syndrome. As an anti-oxidant and neuroprotective agent, its incorporation into the multimodal approach to the management of various kinds of pain has yielded encouraging results and this has helped to minimize the side effects of a single drug, reduce dosing and maximize the synergistic effects of other agents by their different mechanisms of actions. Aim: To assess the effectiveness of ascorbic acid (Vitamin C) as an adjuvant in postoperative pain management among women undergoing cesarean delivery under spinal anesthesia Method: This prospective randomized double-blind study assessed the effectiveness of ascorbic acid (Vitamin C) as an adjuvant in postoperative pain management among women undergoing cesarean delivery under spinal anesthesia at Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA). A total of 164 paturients 18-40 years, with American Society of Anesthesiologists (ASA) I and II undergoing caesarean delivery were recruited for this study and randomly allotted into two groups: Group A (n) =82 received rectal diclofenac, intravenous paracetamol and 1g (10mls) intravenous Vitamin C slowly over 10mins, while Group B (control group) (n) = 82 received rectal diclofenac, intravenous paracetamol and 10mls of sterile water. Both the study drug and placebo will be administered at the end of surgery.
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 Cesarean scetion pain
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 164
Actual target sample size (number of participants) 164
Recruitment status Completed
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 Rectal Diclofenac (50mg), Intravenous Paracetamol (600mg), and 1g (10mls) Intravenous Vitamin C Stat At the end of the surgery, participants will receive suppository diclofenac 50mg, IV paracetamol 600mg, and IV vitamin C 1g (10mL). 82
Control Group Group B Rectal Diclofenac (50mg), Intravenous Paracetamol (600mg), and 10mls of Sterile Water Stat At the end of the surgery, participants will receive suppository diclofenac 50mg, IV paracetamol 600mg, and sterile water (10mL). 82 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA grade I or II Paturients of age 18-40 years. Patients who have given informed written consent. Paturients scheduled to undergo elective Caesarean delivery under subarachnoid block ASA III or greater Emergency Caesarean delivery. Age more than 40 and less than 18. Patient's refusal to participate in the study Caesarean delivery under General Anaesthesia Patients on pain medications prior to surgery Multiple gestation. Co-existing uterine myoma Patients with history of peptic ulcer disease Pre eclampsia Eclampsia Adult: 19 Year-44 Year 18 Year(s) 40 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 22/12/2020 Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
FMC Road Abakaliki 482131 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes were the incidence and severity of postoperative pain. Intravenous vitamin C was considered effective as an adjuvant in immediate postoperative pain management when there is a significant difference in the incidence and/or severity of postoperative pain and time to request analgesia between the study groups Within 24 Hours
Secondary Outcome Side Effects To identify and compare side effects in both groups First 24 Hours Post Cesarean delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital FMC Road Abakaliki Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Promise Ubanatu FMC Road Abakaliki Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Promise Ubanatu FMC Road Abakaliki Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Joseph Olung Achi Department of Anaesthesia, University of Nigeria Teaching Hospital Ituku Ozalla Enugu Nigeria
Donatus O. Egwu Department of Anaesthesia, Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria
Richard Ewah Department of Anaesthesia, Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria
Joshua Adeniyi Adebayo Department of Obstetrics and Gynecology Alex Ekwueme Federal University Teaching Hospital Abakaliki Nigeria
Roland Nnaemeka Okoro Department of Clinical Pharmacy and Pharmacy Administration, University of Maiduguri Maiduguri Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Promise Ubanatu ubanatupromise@gmail.com +2347018773472 Department of Anaesthesia, Alex Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki Nigeria Consultant Anaesthesiologist at Alex Ekwueme Federal University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Roland Okoro orolandn@gmail.com +2348032576716 Bama Road
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior Lecturer at the University of Maiduguri
Role Name Email Phone Street address
Public Enquiries Roland Okoro orolandn@gmail.com +2348032576716 Department of Clinical Pharmacy and Pharmacy Administration, University of Maiduguri
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior Lecturer at the University of Maiduguri
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared on reasonable request Informed Consent Form,Statistical Analysis Plan,Study Protocol One year post-publication Upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information