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.: PACTR202009808358028 Date of Approval: 09/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A COMPARATIVE ANALYSIS OF THE EFFECTS OF INTRATHECAL DEXMEDETOMIDINE AND MORPHINE IN LOWER LIMB ORTHOPAEDIC SURGERY.
Official scientific title A COMPARATIVE ANALYSIS OF THE EFFECTS OF INTRATHECAL DEXMEDETOMIDINE AND MORPHINE IN LOWER LIMB ORTHOPAEDIC SURGERY.
Brief summary describing the background and objectives of the trial In our study, we would like to observe the effects of intrathecal Dexmedetomidine and low-dose intrathecal Morphine in patients undergoing lower limb orthopaedic surgery in order to compare their post-operative analgesic efficacy and their side effect profile. If Dexmedetomidine proves to be as effective as other studies have shown, with a better side effect profile as compared to morphine, it could improve our patient care at Dr George Mukhari Academic Hospital tremendously for our patients undergoing orthopaedic lower limb surgery.
Type of trial CCT
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 SPINAL ANAESTHESIA
Anticipated trial start date 01/01/2020
Actual trial start date 31/03/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 13/01/2021
Anticipated target sample size (number of participants) 82
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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MORPHINE GROUP 100MCG OF MORPHINE INTRATHECALLY WITH 12.5MG OF HYPERBARIC BUPICVACAINE SINGLE SHOT BEFORE PROCEDURE MONITIOR ANALGESIA AND SIDE EFFECTS 41 Active-Treatment of Control Group
Experimental Group DEXMEDETOMIDINE GROUP 10MCG OF DEXMEDETOMIDINE WITH 12.5MG INTRATHECAL HYPERBARIC BUPIVACAINE SINGLE SHOT MONITOR ANALGESIA AND SIDE EFFECTS 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of anaesthesiologists physical status classification: (ASA) ASA I which represents a normal healthy patient. ASA II represents a patient with mild systemic disease. age 18 – 50 male and female A patient presenting for lower limb surgery, whether for an emergency procedure or an elective procedure. Patient refusal Known allergy to Bupivacaine or Dexmedetomidine Pregnancy Lactating Mothers Cardiopulmonary abnormalities Hepatic or renal abnormalities Patient on anticoagulation therapy Spinal cord deformities Local skin site infections Heart block or dysrhythmias Asthma Morbid Obese patient Patients with obstructive sleep apnoea Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 05/09/2019 POSTGRADUATE STUDIES RESEARCH DEVELOPMENT AND ETHICS SEFAKO MAKGATHO UNIVERSITY RESEARCH ETHICS COMMITTEE SMUREC
Ethics Committee Address
Street address City Postal code Country
MOLOTLEGI STREET GA-RANKUWA PRETORIA 0204 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare side effects for both agents observed intra-operatively and post-operatively, which include:  Hypotension  Bradycardia  Respiratory depression  Pruritis  Nausea and vomiting INTRAOPERATIVELY AND POSTOPERATIVELY
Secondary Outcome  To compare the adequacy of post-operative pain control of both agents.  To compare the duration of post-operative pain control by evaluating time to first rescue analgesia in the ward.  To compare the onset time of spinal anaesthesia by evaluating time to reach dermatome level T10 for both agents. INTRAOPERATIVLELY AND POST-OPERATIVELY
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
DR GEORGE MUKHARI ACADEMIC HOSPITAL THEATRE COMPLEX MOLOTLEGI STREET GA-RANKUWA PRETORIA 0204 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Rhona Gouws 101 Pendoring avenue Pretoria South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor RHONA 101 PENDORING PRETORIA 0182 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Theresa Samuel Hartebeespoort Dam Pretoria South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RHONA GOUWS RHONA@HENGELAARSVRIEND.COM 27815916995 101 PENDORING AVENUE
City Postal code Country Position/Affiliation
PRETORIA 0182 South Africa ANAESTHETIC REGISTRAR
Role Name Email Phone Street address
Public Enquiries RHONA GOUWS RHONA@HENGELAARSVRIEND.COM 27815916995 101 PENDORING AVE
City Postal code Country Position/Affiliation
PRETORIA 0182 South Africa ANAESTHESIA REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries RHONA GOUWS RHONA@HENGELAARSVRIEND.COM 27815916995 101 PENDORING AVE
City Postal code Country Position/Affiliation
PRETORIA 0182 South Africa ANAESTHSIA REGISTRAR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data sharing statement of the study, A comparative analysis of the effects of intrathecal dexmedetomidine and morphine in lower limb orthopaedic surgery. Clinical Study Report,Study Protocol within 12 months of completing the data collection spinal anaesthesia side effects analgesia cover dexmedetomidine morphine
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