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.: PACTR202302512721865 Date of Approval: 03/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) versus transversus abdominis plane block (TAP) for postoperative analgesia after abdominoplasty
Official scientific title Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) versus transversus abdominis plane block (TAP) for postoperative analgesia after abdominoplasty
Brief summary describing the background and objectives of the trial Abdominoplasty is a common surgical procedure associated with postoperative pain. Transversus abdominis plane (TAP) block can be done for patients scheduled for abdominoplasty to decrease postoperative analgesic requirements. Although its analgesic effect covers only somatic pain, single-shot TAP block significantly decreases resting pain scores and physical immobility in the postoperative period. Blockage of thoracoabdominal nerves through perichondrial approach (TAPA) is an effective postoperative analgesic method in lower thoracic and abdominal surgery. The modified TAPA (M-TAPA) done by application of the local anesthetic only to the lower aspect of the perichondrium provides adequate analgesia following major abdominal surgeries. The aim of this study is to compare the efficacy of bilateral ultrasound-guided modified thoracoabdominal nerves block (M-TAPA) and bilateral ultrasound-guided transversus abdominis plane (TAP) block in patients undergoing abdominoplasty.
Type of trial RCT
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 Anesthetic technique
Anticipated trial start date 12/02/2023
Actual trial start date 14/02/2023
Anticipated date of last follow up 10/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 84
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group C group For the 1st postoperative 24 hours. Patients will receive systemic analgesia only. 28 Placebo
Experimental Group T group For the 1st postoperative 24 hours. Patients will receive 20mL of local anesthetic (0.25% bupivacaine) of transversus abdominis plane (TAP) block on each side under ultrasound guidance. 28
Experimental Group MT group For the 1st postoperative 24 hours. Patients will receive 20mL of local anesthetic (0.25% bupivacaine) of modified thoracoabdominal nerves block (M-TAPA) on each side under ultrasound guidance. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status grade: I and II patients. Both sexes. Age between 18 and 65 years old. ASA physical status more than grade II. Patients’ refusal. Patients younger than 18 years or older than 65 years. Patients with known hypersensitivity to local anesthetics. Patients with an infection in the surgery site. Patients with mental problems having difficulty understanding the scoring for pain. Contraindications for regional anesthesia (Platelet count <100.000 or any coagulopathy). History of opioid abuse Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/12/2022 Medical Research Ethics Committee. Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Al gomhoria street Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative analgesia immediately, after the 1st hour, 6th hour, 12th hour and 24th hours after the surgery as evaluated by the VAS score. immediately, after the 1st hour, 6th hour, 12th hour and 24th hours
Secondary Outcome The time to the 1st opioid analgesic request, the total consumption of opioids within the 1st 24 hours, hemodynamic instability and any block-related complications. Within the 1st 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals Al gomhoria street Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marina Wasfy Boulos Al gomhoria street Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marina Wasfy Boulos Al gomhoria street Mansoura 35511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marina Boulos marinaonly19@gmail.com +01551886644 Al gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant lecturer of Anesthesia and Surgical Intensive Care. Faculty of medicine. Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohamed El houty dr_mohamedgad2000@yahoo.com +01093019320 Al gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of anesthesia and surgical intensive care. Faculty of medicine. Mansoura University
Role Name Email Phone Street address
Public Enquiries Sameh Ahmed marina2005eg@yahoo.com +01005589289 Al gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assist. Prof. of Anesthesia and Surgical Intensive Care. Faculty of Medicine. Mansoura University
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 de-identification. Study Protocol For 48 months. Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to marinaonly19@gmail.com. To gain access, data requestors will need to sign a data access agreement.
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