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.: PACTR202209703705086 Date of Approval: 23/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF STANDARD DOSE (9MG) VERSUS HIGH DOSE (11MG) HYPERBARIC BUPIVACAINE SPINAL BLOCK WITH REGARDS TO DURATION OF THE BLOCK & HAEMODYNAMIC CHANGES ASSOCIATED WITH EACH DOSE IN PREGNANT PATIENTS UNDERGOING CAESAREAN SECTION DELIVERY IN PRETORIA.
Official scientific title COMPARISON OF STANDARD DOSE (9MG) VERSUS HIGH DOSE (11MG) HYPERBARIC BUPIVACAINE SPINAL BLOCK WITH REGARDS TO DURATION OF THE BLOCK AND HAEMODYNAMIC CHANGES ASSOCIATED WITH EACH DOSE IN PREGNANT PATIENTS UNDERGOING CAESAREAN SECTION DELIVERY IN TWO ACADEMIC HOSPITALS IN THE TSHWANE DISTRICT IN PRETORIA.
Brief summary describing the background and objectives of the trial The aim of the study is to see if using a higher dose of hyperbaric bupivacaine results in the same haemodynamic effects as the low dose i.e. the hypotension between the two doses is the same. If this is proven to be true that there is no significant different the current dose used in spinal blocks will be increased to 11mg with the aim to achieved prolonged spinal block at a higher dosage and reduction in supplementing with analgesia or conversion of spinal block to general anaesthesia which also has its associated complications in pregnant patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied The effect of higher dose hyperbaric bupivacaine on the haemodynamic changes and duration of spinal.
Purpose of the trial To increase the current dosage of hyperbaric bupivacaine
Anticipated trial start date 02/01/2023
Actual trial start date
Anticipated date of last follow up 03/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants)
Recruitment status Not yet 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group B 11 mg STAT dose Patients will be given a higher dosage of hyperbaric bupivacaine and monitored if the blood pressure drop is the same as the control group who have received a standard dos. 38
Control Group Group A 9mg STAT dose This group will be given the standard dose of bupivacaine which is currently being used in our setting and compared with the higher dose given in Group B to see if there is a difference in haemodynamic changes/effects 38 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) All stable pregnant patients undergoing elective caesarean section who are eligible for spinal anaesthesia in participating hospitals. 2) Any patient that is >18 years undergoing elective caesarean section who is eligible for spinal anaesthesia can give consent. 3) American Society of Anaesthesiologists (ASA) Physical Status Classification System I-II patients. 1) Emergency caesarean sections 2) Contraindications to spinal anaesthesia i.e. hypovolemia, valvular heart lesions (mitral or aortic stenosis), coagulation abnormalities, inability to consent, patient refusal to consent to the study, 3) Age < 18 years 4) ASA III and above patients. Adult: 19 Year-44 Year 18 Year(s) 50 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
No 26/10/2022 University of Pretoria
Ethics Committee Address
Street address City Postal code Country
Bophelo Rd pretoria 0084 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To check if there is no difference in haemodynamic changes after giving spinal block with a higher dose of hyperbaric bupivacaine of 11mg versus standard dose of 9mg. Perioperative period
Secondary Outcome Assess the frequency of implementing rescue analgesia, sedation, or conversion to general anaesthesia between the two dosages by indicating any additional drugs given to the patient during the caesarean section for pain or conversion to general anaesthesia. perioperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Steve Biko Academic Hospital and Kalafong Provincial Tertiary Hospital c/o Steve Biko and Malan Street, Klipspringer street Pretoria 0001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Agnes Morosi c/o Malan and Steve Biko Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Agnes Morosi c/o Malan and Steve Biko Rd Pretoria 0001 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Agnes Morosi u20828153@tuks.co.za +27785110593 Steve Biko Academic Hospital
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Medical Registrar
Role Name Email Phone Street address
Public Enquiries Motselisi Mbeki motselisi.mbeki@up.ac.za 27123731053 1 Klipspringer Rd
City Postal code Country Position/Affiliation
Pretoria 0008 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Andries Masenge andries.masenge@up.ac.za 0124203645 Bophelo Rd
City Postal code Country Position/Affiliation
Pretoria 0084 South Africa Statistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol post publication Researchers who provide 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