Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

NCT06588777 | Recruiting DMC

• 1 other identifier: MD92/2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia.

Conditions

Laparoscopic Cholecystectomy; Modified Thoracoabdominal Nerve Block; Quadratus Lumborum Block

Keywords

Laparoscopic cholecystectomy; modified thoracoabdominal nerve block; quadratus lumborum block

Outcome Measures

Primary Outcomes (1)

• Time to first Rescue Analgesia

  Is to measure the first time to resque analgesia postoperative (24 hours)

  24 hours postoperative

Secondary Outcomes (4)

• The total requirements of rescue analgesia Meperidine (pethidine) over the first 24 hours postoperative

  24 hours postoperative

• Heart rate

  at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively

• Blood pressure

  at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively

• Spo2 measuring

  at intervals of 0 (PACU), 1, 2, 4, 6, 12, 18 and 24 hours postoperatively

Study Arms (2)

Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)

EXPERIMENTAL

Using the in plane technique A deep angle was given to the costochondral angle at the edge of the 10th costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 20 mL of 0.25% bupivacaine will be injected into the lower surface of the chondrium to make Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA).

Procedure: Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)

Quadratus lumborum block

EXPERIMENTAL

Using the in plane technique the probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis. The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle.

Procedure: Quadratus lumborum block

Interventions

Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) PROCEDURE

transversus abdominis, internal oblique, and external oblique muscles will be identified with a high-frequency (10 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 costal margin with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 100-mm block needle will be inserted in the cranial direction using the in-plane technique and the needle tip will be moved to the posterior aspect of the 10th costal cartilage. It is noted that the needle tip never crossed the cranial edge of the 10th costal cartilage

Also known as: (M-TAPA)

Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)

Quadratus lumborum block PROCEDURE

using ultrasound guidance (Sonosite turbo M, Bothell, Washington, USA) and a curved ultrasound probe (2.5-7.5 MHz). The probe will be placed in the mid-axillary line between the lower costal margin and the iliac crest in a transverse plane to view all abdominal layers. The probe will be moved towards the posterior axillary line, to reach a point where all three abdominal muscle layers merge to form aponeurosis. The aponeurosis will then be followed dorsally until the quadratus lumborum muscle is seen deep to transversalis fascia with its attachment to the transverse process of the L4 vertebral body. A 22 G, 100 mm, blunt, insulated nerve block needle will be inserted 1 cm medial to the probe and advanced using the in-plane technique with ultrasound real-time assessment. The injection site will be the junction of transversalis fascia and the anterolateral border of quadratus lumborum muscle

Also known as: (QLB)

Quadratus lumborum block

Eligibility Criteria

• Age: 21 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aging ≥ 21 years to ≤ 70 of both sexes.
• Patients undergoing Laparoscopic cholecystectomy surgeries.
• ASA physical status classes I - II.

You may not qualify if:

• Patient's refusal of procedure or participation in the study.
• ASA classes III or above.
• Coagulopathy and bleeding disorders.
• Evidence of Local skin infections at site of injection.
• Body mass index \>40kg/m2
• A history of relevant local anesthetic allergy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university hospitals

Cairo, Egypt

RECRUITING

Central Study Contacts

Ahmed Hassan, Master

CONTACT

01158195158; ahmedhassan199466@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

EG (1)