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.: PACTR202312623511104 Date of Approval: 04/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title M-TAPA block versus subcostal TAP block for analgesia after laparoscopic cholecystectomy, a non-inferiority randomized trial
Official scientific title Modified thoracoabdominal nerve block through perichondral approach versus subcostal transversus abdominus plane block for analgesia after laparoscopic cholecystectomy, a non-inferiority randomized trial
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy (LC) is the mainstay treatment of benign biliary disease. Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after LC. In this study, the postoperative analgesic effect of ultrasound-guided modified thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and oblique subcostal transversus abdominis plane block (OSTAP) will be investigated in patients recruited for LC. It is hypothesized that M-TAPA will reduce opioid consumption of the patients more than the OSTAP block.1,2 Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined for abdominal surgeries. Previously, several studies have reported that ultrasound-guided OSTAP blocks reduce pain scores after LC. Performing OSTAP can be challenging in obese patients or in patients with transverse abdominal incisions for previous surgeries. 3 4,5 M-TAPA block is performed by applying local anesthetic to the lower surface of the chondrium resulting in effective analgesia in the abdominal wall resulting in wider dermatomal analgesia through blocking the anterior and lateral branches of thoracoabdominal nerves T5-L.6 This study aims to compare the efficacy of M-TAPA block as an alternative to OSTAP for analgesia after laparoscopic cholecystectomy. The hypothesis of this study is that M-TAPA is an equivalent alternative to OSTAP producing comparable analgesic profile. The primary objective will the mean postoperative numeric rating scale (NRS) score in the 1st postoperative day, while secondary objectives will include the hourly postoperative NRS score after surgery at rest and at movement, postoperative morphine consumption, the incidence of postoperative nausea and vomiting (PONV).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/12/2023
Actual trial start date 05/12/2023
Anticipated date of last follow up 20/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group T group A 20 ml of 0.25% bupivacaine will be injected bilaterally between internal oblique muscle and transversus abdominus muscle. The block will be performed after intubation with the patient before start of surgery and the patient will be followed for 24 hours The US probe was placed on the upper abdominal wall obliquely along the subcostal edge close to the midline. After identification of the rectus abdominis muscle (RAM), by shifting the probe obliquely along the subcostal line toward the lateral, the transverse abdominis muscle (TAM) will be located below the RAM. With the USG probe, an 80 mm, 22-gauge block needle will be placed between the RAM and TAM in the same plane (in-plane technique). 32 Active-Treatment of Control Group
Experimental Group M group 20 mL of 0.25% bupivacaine was injected into the lower surface of the chondrium. the injection will be performed after anesthesia induction and before surgery. Patient will be followed for 24 hours M-TAPA was performed bilaterally by a single anesthesiologist, Following the tracheal intubation and before the surgical procedure, transversus abdominis, internal oblique, and external oblique muscles were identified with a high-frequency (12 MHz) linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. A deep angle was given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 21-G, 80-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip was moved to the posterior aspect of the 10th costal cartilage 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients anesthesiologist physical status I and II scheduled for laparoscopic cholecystectomy previous midline incisions, neuromuscular disease known allergies to the study medications Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 29/11/2023 Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean postoperative numeric rating scale 24 hours after surgery
Secondary Outcome postoperative morphine consumption in milligrams 24 hours after surgery
Secondary Outcome the incidence of postoperative nausea and vomiting 24 hours after suregry
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Elgomhoreya street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Elgomhoreya Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoreya atreet Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor of anesthesia Mansoura University Egypt
Role Name Email Phone Street address
Public Enquiries Alreafey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor of anesthesia Mansoura University Egypt
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor of anesthesia Mansoura University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes anonymized IPD will be available 6 months after study completion upon request from the main investigator Informed Consent Form,Statistical Analysis Plan,Study Protocol data will be available within 6 months after study completion Data shall be available for researchers or organization covered by an ethical committee after contacting main investigator clarifying a proper cause of requesting
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