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.: PACTR201707002398224 Date of Approval: 01/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF SINGLE-DOSE PREOPERATIVE DEXAMETHASONE ON POSTOPERATIVE PAIN, NAUSEA AND VOMITING FOLLOWING BREAST SURGERY
Official scientific title EFFECT OF SINGLE-DOSE PREOPERATIVE DEXAMETHASONE ON POSTOPERATIVE PAIN, NAUSEA AND VOMITING FOLLOWING BREAST SURGERY
Brief summary describing the background and objectives of the trial Background Post-operative pain, nausea and vomiting contribute significantly to morbidity after breast surgery. Dexamethasone has been found to be an effective adjunct in multimodal strategies to reduce post-operative pain and opioid consumption. The development of persistent postoperative pain following breast surgery has also been linked with inadequately treated acute postoperative pain. In the West African sub-region, very little data exists on the effect of perioperative steroid administration on post-operative pain, nausea and vomiting following breast surgery. Objectives of this trial are: To determine in patients who have breast surgery at the Korle Bu Teaching Hospital: 1. The effect of single dose preoperative dexamethasone on the incidence and severity of postoperative pain 2. The effect of single dose preoperative dexamethasone on the incidence of postoperative nausea and vomiting (PONV) 3. The effect of single dose preoperative dexamethasone on postoperative blood glucose levels
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postoperative pain, nausea and vomiting post-breast surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/07/2016
Actual trial start date 14/09/2016
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 02/01/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
KBTH-IRB /00013/2016 Korle Bu Teaching Hospital Institutional Review Board
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Once participant is enrolled the principal investigator (PI) picks a ballot from a box of sealed opaque ballots coded by another investigator who keeps the key to the codes to determine which coded arm of the study they will belong to The investigator who holds the key to the generated codes keeps it secret and will only reveal the key to the codes after the data analysis stage Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal saline 2 ml stat, before induction of anaesthesia Once, just before induction of anaesthesia 2 ml of saline is given intravenously just before induction of anaesthesia 50 Placebo
Experimental Group Intravenous dexamethasone 8mg stat Once, just before induction of anaesthesia 8mg of IV dexamethasone (total volume 2ml) is given once, just before induction of anaesthesia 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA I and II patients coming for elective breast surgery History of allergy to dexamethasone History of gestational diabetes or diabetes mellitus Patients on chronic steroid therapy Immunosuppression and patients on immunosuppressant drugs History of motion sickness and/or previous PONV after any surgical procedure History of peptic ulcer disease Patients with advanced breast disease for palliative procedures (e.g. toilet mastectomy) 18 Year(s) 70 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 04/07/2016 Korle Bu Teaching Hospital Institutional Review Board (KBTH-IRB)
Ethics Committee Address
Street address City Postal code Country
P. O. Box 77 Accra Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence and severity of postoperative pain Immediate postop 4 hours postop 8 hours postop 24 hours postop
Primary Outcome Incidence and severity of postoperative nausea and vomiting Immediate postop 4 hours postop 8 hours postop 24 hours postop
Secondary Outcome Blood glucose levels Preoperatively, just before intervention 4 hours postop 8 hours postop 24 hours postop
Secondary Outcome Total amount of opioid used in the first 24 hours postop 24 hours postop
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Surgery Korle Bu Teaching Hospital Alexander Avenue, Korle Bu Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Papa Kobina Gyakye deGraft-Johnson Court 2B Alexander Avenue Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Papa Kobina Gyakye deGraft-Johnson Court 2B Alexander Avenue, Korle Bu Accra Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Ernest Aniteye 8 Slater Avenue, KorleBu Accra Ghana
Dr. Robert Djagbletey House number B837/18 Ekpakpafeemo Street Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Papa Kobina Gyakye deGraft-Johnson kobby83@hotmail.com +233 26 669 9724 Court 2B Alexander Avenue
City Postal code Country Position/Affiliation
Accra Ghana Anaesthesiologist/Dept of Anaesthesia, KorleBu Teaching Hospital
Role Name Email Phone Street address
Public Enquiries IRB Administrator's Office Korle Bu Teaching Hospital rdo@kbth.gov.gh +233 30 266 6766 Alexander Avenue
City Postal code Country Position/Affiliation
Accra Ghana Institutional Review Board
Role Name Email Phone Street address
Scientific Enquiries Papa Kobina Gyakye deGraft-Johnson kobby83@hotmail.com +233 26 669 9724 Court 2B Alexander Avenue
City Postal code Country Position/Affiliation
Accra Ghana Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information