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.: PACTR202011806750124 Date of Approval: 05/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PAIN MANAGEMENT IN EARLY POST-OPERATIVE PERIOD AFTER EMERGENCY AND ELECTIVE GENERAL SURGICAL PROCEDURES USING TRANSDERMAL BUPRENORPHINE PATCH SYSTEM IN GEORGE MUKHARI ACADEMIC HOSPITAL
Official scientific title PAIN MANAGEMENT IN EARLY POST-OPERATIVE PERIOD AFTER EMERGENCY AND ELECTIVE GENERAL SURGICAL PROCEDURES USING TRANSDERMAL BUPRENORPHINE PATCH SYSTEM IN GEORGE MUKHARI ACADEMIC HOSPITAL
Brief summary describing the background and objectives of the trial This study assesses the efficiency of the buprenorphine patch system compared to the routine use of tramal (tramadol) intra-muscular injections in the context of the South African public healthcare sector. The study showed that the use of the buprenorphine patch is a reliable and effective method of post-operative analgesia, although it is slightly more expensive compared to the routine use of Tramal. The pain control was found very effective in the settings of Dr George Mukari Academic Hospital (DGMAH). The buprenorphine patch showed significantly better results in all assessed scenarios; thus, it may be recommended for use at the DGMAH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/07/2017
Actual trial start date 04/07/2017
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date 25/12/2017
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Completed
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Buprenorphine patch buprenorphine patch 5 mcg/h 2 days we applied buprenorphine patch and compared its efficacy to routin tramal injections 75
Control Group tramal 100 mg IMI TDS 2 days IMI injections 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients between the age 18–70 years; • Patients who have undergone elective and/or emergency abdominal surgery either laparoscopic or open. • Known hypersensitivity to buprenorphine; • Delirium tremens; • Patients with severe hepatic impairment; • Patients suffering from myasthenia gravis; • Patients with head injury; • Patients with a depressed level of consciousness; • Patients with known alcohol or substance abuse; • Patients with impaired respiratory function; • Patients concurrently receiving MAOIs; • Trauma patients; • Pregnant patients; • Consent refusal. 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 03/11/2016 Postgraduate Studies Research Development IntegrityEthics Sefako Makgatho University Research Ethics Committee SMUREC
Ethics Committee Address
Street address City Postal code Country
Molotlegi St, Ga-Rankuwa Zone 1, Ga-Rankuwa, 0208, South Africa Pretoria 0204 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The buprenorphine patch is a perfect pain control regimen as it has better pain control and provides better comfort in all significant assessed areas of discomfort, such as insomnia, nausea, vomiting, nightmares, sweating, itching, constipation, lack of appetite, tiredness and cognitive difficulties. For example, pain at its worst was rated on Day 2 at the level of 3,49 in the buprenorphine group versus 5,79 in the tramal group. Nausea was 1,65 in the tramal group versus 0,48 in the buprenorphine group. Constipation was 2,82 in tramal group versus 1,03 in the buprenorphine group. Vomiting was rated at the level of 0,99 on Day 2 in the tramal group versus 0,07 in the buprenorphine group. The buprenorphine patch showed significantly better results in all assessed scenarios; thus, it may be recommended for use at the DGMAH 2 days
Secondary Outcome The use of the buprenorphine patch showed a slight increase in costs compared to the tramal group (R7800,75 vs R7537,50) in the whole study, which is a mild difference that is greatly outweighed by significant convenience and better outcomes. south african rands
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
doctor george mukhari academic hospital 3111 Setlogelo Drive, Ga-Rankuwa Unit 2 Pretoria 0208 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
andriy kirpichnikov the principal ivestigator unit 38 19 a norton street, leichhardt sydney 2040 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Andriy Kirpichnikov unit 131, Morgenhof estate, daan de weet street Pretoria 0204 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Z M Koto Molotlegi St, Ga-Rankuwa Zone 1, Ga-Rankuwa, pretoria 0208 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andriy Kirpichnikov and.kirpichnikov@gmail.com +61426075622 unit 18, 19a-23 Norton street, Leichhardt, NSW
City Postal code Country Position/Affiliation
Sydney 2040 Australia Upper GI HPB fellow
Role Name Email Phone Street address
Public Enquiries Faizullah Ghoor drghoor@hotmail.com +27829260271 Molotlegi St, Ga-Rankuwa Zone 1, Ga-Rankuwa, 0208, South Africa
City Postal code Country Position/Affiliation
Pretoria 0208 South Africa Professor
Role Name Email Phone Street address
Scientific Enquiries Zacharia Koto zachkoto@gmail.com +270824553322 Molotlegi St, Ga-Rankuwa Zone 1, Ga-Rankuwa, 0208, South Africa
City Postal code Country Position/Affiliation
Pretoria 0208 South Africa SMU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes By what mechanism will date be made available Data are available indefinitely at (Link to be included) What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, andappendices) What other documents will be available? Study Protocol When will data be available (start and end date)? Immediately following publication, No end date With who? Anyone who wishes to access the data For what types of analyses? Any purpose By what mechanism will date be made available? Data are available indefinitely at (Link to be included) Baseline characteristics: This study assesses the efficiency of the buprenorphine patch system compared to the routine use of tramadol intra-muscular injections in the context of the South African public healthcare sector. Patients were randomised into two groups, who received routine tramadol injections and buprenorphine patches, respectively. The study looked at the first 48 hours of the immediate post-operative period. A visual pain scale was used to assess the level of post-operative pain as well as all major complications associated with tramadol and/or insufficient analgesia. Console diagram of the RCT 160 patients were eligible 150 patients were randomly assigned 75 patients received buprenorphine patch 5mcg/h No patients were lost for follow up or discontinued treatment 75 patients were analyzed 75 patients received Tramadol injections 100 mg TDS. No patients were lost for follow up or discontinued treatment 75 patients were analyzed 10 patients were excluded (did not meet the criteria) Adverse events: None Results/ Outcome measures: The sample size included 75 patients in Group A (tramal) and 75 patients in Group B (buprenorphine patch group). Nine patients (12%) of those who received the patch subsequently required additional analgesia. Clinical Study Report,Informed Consent Form,Study Protocol 6 months Anyone with appropriate qualification can access data after approval is granted by me
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