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.: PACTR201807735986564 Date of Approval: 26/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomised controlled trial comparing the spinal sensory level achieved, duration of action and safety of generic (Bupivacaine 0.5% with Dextrose-PharmaQ) versus original bupivacaine (Macaine 0.5% with dextrose-Adcock Ingram) in spinal anaesthesia
Official scientific title Randomised controlled trial comparing the spinal sensory level achieved, duration of action and safety of generic (Bupivacaine 0.5% with Dextrose-PharmaQ) versus original bupivacaine (Macaine 0.5% with dextrose-Adcock Ingram) in spinal anaesthesia
Brief summary describing the background and objectives of the trial To date, there are no clinical trials comparing generic local anaesthetics to the parent drug. With the increasing use of generic medicines and the cost saving implications it is important to have clinical trials to compare the efficacy of these generic drugs. In this randomised control trial we will be comparing the original bupivacaine (with dextrose) produced by Adcock Ingram to generic bupivacaine with dextrose produced by PharmaQ. We will look at the clinical effects as well as side effects procduced by performing spinal anaesthesia with the original bupivacaine in one group, and with the generic in another equivalent group of patients. We will compare the sensory level achieved after 5, 30, 60, and 90 minutes, as well as any side effects. With this study we aim to find out if is any difference in the clinical effects and side effect profile of the original bupivacaine compared to the much cheaper generic bupivacaine that is currently in use at Steve Biko Academic Hospital
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not applicable
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 31/07/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 Original formulation Adcock Ingram Single dose adjusted for patient's weight and height Once off Spinal anaesthesia will be performed in the sitting position, with a 26g pencil point needle, with the original formulation of Bupivacaine 36 Active-Treatment of Control Group
Experimental Group Generic formulation of bupivacaine Single dose according to patient's weight and height Once off Spinal anaesthesia in the sitting position, using a 26g pencil point needle, using generic bupivacaine 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male patients 18 - 50 years old Healthy patients - American Society of Anaesthesiologists physical status grade one and two Contraindication to spinal anaesthesia Local anaesthetic allergy Patient refusal Adult: 19 Year-44 Year 18 Year(s) 50 Year(s) Male
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 20/06/2018 University of Pretoria Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Pretoria - Faculty of Health Sciences Pretoria 0002 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparing the sensory level achieved by generic to the original drug 5 minutes after injection
Secondary Outcome Comparing the decrease in the sensory level after 30, 60 and 90 minutes 30, 06 and 90 minutes after injection
Secondary Outcome Comparing the side effects observed betwen generic and original drug For 90 min duration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Steve Biko Academic Hospital Corner of Steve Biko Road and Malan Street Pretoria 0002 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pireshin Ramdharee 206 Outeniqua Avenue Pretoria 0181 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Sheila Naidoo Kalafong Hospital, 1 Klipspringer Street Pretoria 0008 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pireshin Ramdharee pireshin87@gmail.com +27845065211 206 Outeniqua Avenue
City Postal code Country Position/Affiliation
Pretoria 0181 South Africa Principle investigator
Role Name Email Phone Street address
Public Enquiries Pireshin Ramdharee pireshin87@gmail.com +27845065211 206 Outeniqua Avenue
City Postal code Country Position/Affiliation
Pretoria 0181 South Africa Principle investigator
Role Name Email Phone Street address
Scientific Enquiries Pireshin Ramdharee pireshin87@gmail.com +27845065211 206 Outeniqua Avenue
City Postal code Country Position/Affiliation
Pretoria 0181 South Africa Principle investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Clinical research form Clinical Study Report,Informed Consent Form,Study Protocol 10 years starting January 2019 Open access for all interested All requests will be reviewed by primary investigator
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