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.: PACTR202407850473997 Date of Approval: 16/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative Dexamethasone Compared with Placebo as an Adjunct Pain Relief on Women Undergoing Caesarean Section at Federal Medical Centre, Owo: Randomized Controlled Trial
Official scientific title Perioperative Dexamethasone Compared with Placebo as an Adjunct Pain Relief on Women Undergoing Caesarean Section at Federal Medical Centre, Owo: Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Caesarean section is associated with tissue damage which results in release of chemical mediators that stimulate inflammatory response by nociceptors. This leads to postoperative pain which is the major complaint after Caesarean section. Opioids are majorly used for postoperative analgesia. However, its use is associated with some unwanted side effects which limit its availability and appropriate use. Dexamethasone is a glucocorticoid which has an anti-inflammatory role and may reduce the need for opioids consumption or the dose required for postoperative pain with additional benefit on postoperative nausea and vomiting. Objectives of the study are: i. To assess for postoperative pain scores after Caesarean section in FMC, Owo. ii. To determine the time for first request for postoperative analgesia in women who had Caesarean section in FMC, Owo. iii. To assess opioid (pentazocine) sparing effect in women who had Caesarean section in FMC, Owo. iv. To determine the effect of Dexamethasone on postoperative nausea and vomiting in women who had Caesarean section in FMC, Owo. v. To determine the effect of Dexamethasone on postoperative haemodynamic status in women who had Caesarean section in FMC, Owo. vi. To assess for patient’s satisfaction to this intervention.
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 None
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/07/2024
Actual trial start date 05/07/2024
Anticipated date of last follow up 06/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 146
Actual target sample size (number of participants)
Recruitment status 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 Allocation was determined by the holder of the sequence who is situated off site 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 Dexamethasone 8mg stat once Intravenous dexamethasone given after clamping of cord at Caesarean section 73
Control Group Normal saline 2mL Once Intravenous normal saline given as placebo after clamping of cord at Caesarean section 73 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Women within the ages of 18 to 35 years ii. Women who gave written informed consent iii. No contraindication to spinal anaesthesia iv. American Society of Anesthesiologists’ physical status (ASA class I and II) i. Patient’s refusal ii. History of glaucoma iii. History of chronic pain iv. History of allergy to steroid v. Chronic use of steroid vi. Need for general anaesthesia vii. Patients with Antepartum haemorrhage viii. Body mass index at booking < 18kg/m2 or >30kg/m2 Adult: 19 Year-44 Year 18 Year(s) 35 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 02/07/2024 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Michael Adekunle Ajasin Road, Owo, Ondo state Owo 1053 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome i. Postoperative pain scores with verbal rating scale assessment. ii. Time to first analgesia request. iii. Dose of opioid (pentazocine) required in 24 hours. iv. Haemodynamic status of the patient. 1, 2,4 and 24 hours after surgery
Secondary Outcome i. Patients with postoperative nausea and vomiting. ii. Satisfaction of the patients to the intervention using Likert scale. 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Owo Michae Adekunle Ajasin Road Owo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adebayo Saheed Yomi Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo Owo Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adebayo Saheed Yomi Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo Owo Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saheed Yomi sirhid1005@gmail.com +2347067959789 Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Saheed Adebayo sirhid1005@gmail.com +2347067959789 Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Saheed Adebayo sirhid1005@gmail.com +2347067959789 Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo Nigeria Senior registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data summary results. All of the Individual Participant Data collected during the trial after deidentification Study Protocol 6 months to 1 year Open
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