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.: PACTR202310828674007 Date of Approval: 12/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative Analgesic Effects of Intravenous Dexamethasone for Patients Undergoing Cesarean Delivery under Spinal Anesthesia at Dilla University Referral Hospital, Ethiopia, 2021: A randomized Controlled Trial.
Official scientific title Postoperative Analgesic Effects of Intravenous Dexamethasone for Patients Undergoing Cesarean Delivery under Spinal Anesthesia
Brief summary describing the background and objectives of the trial The use of cesarean sections worldwide has increased to unprecedented levels. In Ethiopia, the cesarean section delivery rate is above the rate recommended by the WHO. The postoperative pain experience is moderate to severe in most patients during their postoperative period. Administration of intravenous dexamethasone is thought to have an analgesic effect after surgery even though the analgesic profile of preoperatively administered dexamethasone is less addressed. This study aimed to assess the postoperative analgesic effect of preoperative intravenous dexamethasone for patients undergoing cesarean delivery under spinal anesthesia at Dilla University Referral Hospital, Southern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/01/2022
Actual trial start date 10/01/2022
Anticipated date of last follow up 10/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline 2ml of Normal saline followed for 24hrs postoperatively Group I took 2ml of Normal saline which was labelled as 01 with opaque paper 56 Placebo
Experimental Group Dexamethasone 2ml of 8mg of dexamethasone Followed for 24hrs Group II took 2ml of 8mg of dexamethasone which was labelled as 02 was immediately administered before surgery after spinal anesthesia. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA II parturient mothers who underwent elective caesarean delivery under spinal anesthesia. - Diabetes mellitus, heart failure. - Patient with preeclampsia, eclampsia - Patients unable to self-report acute pain - Cognitive impairment (Dementia, Alzheimer's). - Acute/chronic pain diagnosis 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 20/12/2019 DURH IRB
Ethics Committee Address
Street address City Postal code Country
419/13 Dilla 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Time to first analgesic request, Total analgesic consumption in 24hr, postoperative pain score Within 24hrs
Secondary Outcome respiratory rate, SPO2 and PONV Within 24hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral Hospital 419/13 Dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University 419/13 Dilla 419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University 419/13 Dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mesfin Gurmu mesfingurmu92@gmail.com +251924081119 419/13
City Postal code Country Position/Affiliation
Dilla Ethiopia Primary author
Role Name Email Phone Street address
Scientific Enquiries Seyoum Hailu seyoumhailu44@gmail.com +251968060649 419/13
City Postal code Country Position/Affiliation
Dilla 419 Ethiopia Corresponding Author
Role Name Email Phone Street address
Public Enquiries Hailemariam Mulugeta hmerry1990@gmail.com +251970415208 419/13
City Postal code Country Position/Affiliation
Dilla 419 Ethiopia second Author
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide any information upon request by the authorized body within 12 months of the study completion date. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 months of the study completion date. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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