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.: PACTR202302636387329 Date of Approval: 03/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Opioid-free versus Opioid-based Anaesthesia for Thyroidectomy: A comparative Study of Effectiveness and Safety at the Korle-Bu Teaching Hospital
Official scientific title Opioid-free versus Opioid-based Anaesthesia for Thyroidectomy: A randomized single blind comparative study of Effectiveness and Safety at the Korle-Bu Teaching Hospital (KBTH), Accra, Ghana
Brief summary describing the background and objectives of the trial Opioids together with paracetamol are the mainstay for acute pain management following thyroidectomies in KBTH. Acute pain relief is usually required during the first 24 hours after thyroidectomy. Post-operative analgesia has been demonstrated to be inadequate in the surgical unit of KBTH. A study done by Amponsah in 2007 showed an incidence of postoperative nausea and vomiting (PONV) of 34.6%. It is well documented that opioids contribute significantly to PONV. Opioid induced PONV is a particularly significant problem following head and neck surgery where venous engorgement during Valsalva manoeuvre associated with retching and vomiting may precipitate bleeding. Opioid-based anaesthesia intraoperatively has been demonstrated to result in increased opioid requirements postoperatively with its attendant side effects like, PONV, opioid induced hyperalgesia, respiratory depression, pruritus and constipation leading to increased morbidity and prolonged hospital stay. Opioid-free anaesthesia (OFA) may improve postoperative outcomes by decreasing opioid-related adverse effects. This study aims to evaluate the effects of OFA on intraoperative haemodynamic effects as well as PONV, pain scores, sedation, pruritus , hypoxia and respiratory depression. The objectives of this study are to compare for adult patients receiving opioid-free and those receiving opioid-based anaesthesia for thyroidectomy at the Korle Bu Teaching Hospital the following parameters: 1. Intraoperative systolic blood pressure, mean arterial blood pressure and heart rate. 2. Immediate (1 hour) postoperative heart rate, systolic blood pressure and mean arterial blood pressure. 3. Numerical Rating Score at 1, 2, 6, 18, 20 and 24 postoperative hours. 4. Incidence of postoperative nausea and vomiting, sedation, pruritus, hypoxia, respiratory depression at 1, 2, 6, 18, 20 and 24 postoperative hours.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/10/2022
Actual trial start date 10/10/2022
Anticipated date of last follow up 06/03/2023
Actual Last follow-up date 13/03/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 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
Control Group Opioid Based Anaesthesia and Analgesia Intraoperatively and first 24 hours after surgery Induction of anaesthesia: Midazolam 0.03mg/kg, fentanyl 2mcg/kg, and propofol 1.5-2 mg/kg. Intraoperative analgesia: Intravenous(IV) morphine 0.1mg/kg lean body weight. If baseline heart rate and mean arterial blood pressure rise above 30% of baseline values, patients will be given an additional 0.05mg/kg lean body weight morphine. Postoperatively: IV morphine 0.1mg/kg lean body weight will be given 4 hourly as well as IV paracetamol 1g 6 hourly. 50mls of normal saline will be perfused over 24 hours . 25 Active-Treatment of Control Group
Experimental Group Opioid Free Anaesthesia and Analgeisa Intraoperatively and the first 24 hours after surgery Induction of anaesthesia: Intravenous(IV) midazolam 0.03mg/kg, clonidine 1mcg/kg, lidocaine 1mg/kg, propofol 1.5-2mg/kg. Maintenance of anaesthesia: Isolfurane 1-2% Minimum Alveolar Concentration. Intraoperative analgesia : IV dexamethasone 0.15mg/kg, clonidine 2mcg/kg/hour (hr), ketamine 0.25mg/kg/hr, magnesium sulphate 20mg/kg over 1 hour, IV paracetamol 1g bolus and IV ketorolac 30mg bolus. If heart rate and mean arterial blood pressure rises 30% above baseline values, patients will be given IV morphine 0.05mg/kg lean body weight bolus. Postoperative analgesia : continuous infusion of nefopam 60mg with magnesium sulphate 20mg/kg in 50mls of normal saline over 24 hours and IV paracetamol 1g 6 hourly. Breakthrough pain will be treated with IV morphine 0.1mg/kg lean body weight 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All American Society of Anaesthesiologists (ASA) classes I and II patients aged 18 to 70 years presenting for elective thyroidectomy at the Korle-Bu Teaching Hospital 1. Documented adverse reactions to any of the drugs used in the study 3. Premedication with opioid or non-opioid analgesics 4. Patients with uncontrolled cardiovascular disease 5. Patients on beta blockers 6. Inability to use the numeric rating scale for pain assessment 7. Diabetic Patients Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
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 21/06/2022 Korle Bu Teaching Hospital Scientific and Technical Committee or Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Guggisberg Avenue Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative Mean Arterial Blood pressure Every 15 minutes intraoperatively
Secondary Outcome Postoperative Pain using the Numerical Rating Score 1, 2, 6, 18, 20 and 24 postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Guggisberg Avenue, Accra Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Owusu SekyereDanso Alexander Avenue Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Owusu Sekyere Danso Korle-Bu Teaching Hospital Doctors Flats, Block H , Flat 6 . Alexander Avenue Accra Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Owusu Sekyere Danso dockosdy@outlook.com 00233207400388 Alexander Avenue , Korle Bu Doctors Flats Block H flat 6, Accra Ghana
City Postal code Country Position/Affiliation
Accra Ghana Specialist Anaesthesiologist
Role Name Email Phone Street address
Principal Investigator Owusu Sekyere Danso dockosdy@outlook.com +233207400388 Alexander Avenue
City Postal code Country Position/Affiliation
Accra Ghana Specialist Anaesthesiologist at Korle Bu Teaching Hospital Department of Anaesthesia
Role Name Email Phone Street address
Public Enquiries Victor Nortey vonnortey@gmail.com +233245194761 Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Institutional Review Board Human Resource Manager
Role Name Email Phone Street address
Scientific Enquiries George Obeng Adjei gadjei@ug.edu.gh +233208114973 Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Chairman Korle Bu Teaching Hospital Scientific and Technical Commitee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be made available after de-identification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication and ending 5 years following article publication Researchers who provide a methodologically sound proposal
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