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.: PACTR202208499106275 Date of Registration: 10/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ANALGESIC EFFICACY OF BUPIVACAINE VERSUS BUPIVACAINE PLUS MAGNESIUM SULPHATE IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOLLOWING ABDOMINAL GYNAECOLOGICAL SURGERY
Official scientific title ANALGESIC EFFICACY OF BUPIVACAINE VERSUS BUPIVACAINE PLUS MAGNESIUM SULPHATE IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOLLOWING ABDOMINAL GYNAECOLOGICAL SURGERY
Brief summary describing the background and objectives of the trial Background: Abdominal gynaecological surgeries such as Abdominal Hysterectomy, Salpingectomy, Oophorectomy, Cystectomy, Colporrhaphy and Exploratory Laparotomy are associated with moderate to severe pain affecting the lower thoracic and lumbar nerve roots. Several regional techniques are available for managing post-operative pain such as Epidural analgesia, Rectus sheath block, Ilioinguinal, Iliohypogastric and Transversus Abdominis Plane block. The addition of adjuncts to local anaesthetics can be used to prolong the effect of regional blocks. In this study, Bupivacaine with or without Magnesium Sulphate will be used with a point of care ultrasound in a Transversus Abdominis Plane block to assess post-operative analgesic efficacy. Objective: To compare the analgesic efficacy of plain Bupivacaine versus Bupivacaine with Magnesium Sulphate in ultrasound guided Transversus Abdominis Plane block for abdominal gynaecological surgery. Method: This would be a prospective randomized, controlled, double-blind study involving 82 women, between ages 18 - 64 years American Society of Anaesthesiologist physical status I – III patients scheduled for elective Abdominal Hysterectomy, Salpingectomy, Oophorectomy and Cystectomy under general anaesthesia. Ethical clearance would be obtained from Lagos State University Teaching Hospital health research and ethics committee and a written informed consent will be obtained from all patients. The patients would be randomized into 2 groups; Group BP (n = 41) will receive 18ml 0.25% Bupivacaine with 2ml NS and group BM (n = 41) will receive 18ml 0.25% Bupivacaine with 2ml (200mg) MgSO4 in ultrasound – guided Transversus Abdominis Plane block executed on both sides of the abdomen after completion of surgery under GA. Pain scores will be assessed using the numerical rating scale (NRS) score at 2, 4, 6, 8,12 and 24 hours. The time to first request for rescue analgesia, duration of post-operative analgesia and finally patients’ satisfaction will be recorded using Likert scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TAPBfAGYN
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Benign and malignant Gynaecological diseases
Purpose of the trial Post operative Pain intervention
Anticipated trial start date 01/09/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants) 82
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bupivacaine and normal saline 18ml 0.25% Bupivacaine with 2ml of normal saline Single shot Bilateral ultrasound – guided Transversus Abdominis Plane block 41 Active-Treatment of Control Group
Experimental Group Bupivacaine and Magnesium Sulpate 18ml of 0.25% Bupivacaine and 2ml(200mg) Magnesium Sulphate Single shot Bilateral transversus abdominis plane block 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anaesthesiologists physical status class I – III female adults scheduled for elective abdominal surgery Myomectomy Patients’ refusal History of relevant drug allergies Patients on calcium channel blockers Opioid dependence Localised skin infection at site of block Patient with sepsis Patient with coagulation disorders Obese patients with BMI > 35kg/m2 Psychiatric illness that would interfere with the perception and assessment of pain Intra operative finding of a frozen pelvis Intra operative finding of extensive tissue adhesions Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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
Yes 15/06/2022 Health Research and Ethics Committee Lagos state university teaching hospital
Ethics Committee Address
Street address City Postal code Country
Oba Akinjobi road, G.R.A. Ikeja Lagos 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the pain scores following TAPB using 0.25% plain bupivacaine with or without MgSO4. Pain scores will be assessed using the numerical rating scale score at 2, 4, 6, 8,12 and 24 hours
Secondary Outcome Compare duration of analgesia following TAPB using 0.25% plain bupivacaine with or without MgSO4. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos state university teaching hospital Oba Akinjobi road, G.R.A. Ikeja Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Olatunde Towobola 108 Dopemu road Agege Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Olatunde Towobola 108 Dopemu road, Agege Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olatunde Towobola tundetowobola@yahoo.co.uk +2348033193932 108 Dopemu road Agege
City Postal code Country Position/Affiliation
Lagos Nigeria Senior registrar Dept of Anaesthesiology Lagos state university teaching hospital
Role Name Email Phone Street address
Scientific Enquiries YA Kuyinu dcst@lasuth.org 080223207440 Oba Akinjobi road G.R.A. Ikeja
City Postal code Country Position/Affiliation
Lagos 21005 Nigeria Chairman LASUTH HREC
Role Name Email Phone Street address
Public Enquiries Tolu Alakija dcst@lasuth.org +2348055262563 Oba Akinjobi road, G.R.A Ikeja
City Postal code Country Position/Affiliation
Lagos 21005 Nigeria Secretary LASUTH HREC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in the study of pain and analgesia. Data or samples shared will be coded, with no Protected Health Information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 18 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tundetowobola@yahoo.co.uk
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