A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC)

NCT ID: NCT06810206

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-01-31

Brief Summary

Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A: 30 patients will receive the MTAPA.

Group Type: ACTIVE_COMPARATOR

Bilateral Ultrasound Guidance M-TAPA

Intervention Type: OTHER

transversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be 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. The 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, and saline (5 ml) will be injected to confirm the location by observing dissection between internal oblique muscle and transversus abdominis muscle under the 10th costal cartilage, and local anesthetic will be injected into the lower surface of the chondrium. The local anesthetic to be used is bupivacaine 0.25% with Ultrasound Siemens® ACUSON X300 portable scanner with a high frequency linear transducer (10 MHz) using A Quincke 22 G . x 3½ in. (0.7x88 mm) A spinal needle

Group B

Group B: 30 patients will receive the EOIPB.

Group Type: ACTIVE_COMPARATOR

Bilateral Ultrasound Guidance EOIPB

Intervention Type: PROCEDURE

The patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hydro-dissection with 2 ml of 0.9% saline to confirm the correct needle tip position, LA injection will be given. The same procedure will then be repeated on the contralateral

• Local anesthetics to be injected: iBupivacaine (0.25%)
• Dose : 25ml on each side
• Device to be used: Ultrasound Siemens® ACUSON X300 portable scanner with a high-frequency linear transducer (10 MHz) that is covered in sterile plastic.
• Needle to be used : A Quincke 22 G . x 3½ inch (0.7x88 mm) spinal needle

Interventions

Bilateral Ultrasound Guidance M-TAPA

transversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be 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. The 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, and saline (5 ml) will be injected to confirm the location by observing dissection between internal oblique muscle and transversus abdominis muscle under the 10th costal cartilage, and local anesthetic will be injected into the lower surface of the chondrium. The local anesthetic to be used is bupivacaine 0.25% with Ultrasound Siemens® ACUSON X300 portable scanner with a high frequency linear transducer (10 MHz) using A Quincke 22 G . x 3½ in. (0.7x88 mm) A spinal needle

Intervention Type: OTHER

Bilateral Ultrasound Guidance EOIPB

The patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hydro-dissection with 2 ml of 0.9% saline to confirm the correct needle tip position, LA injection will be given. The same procedure will then be repeated on the contralateral

• Local anesthetics to be injected: iBupivacaine (0.25%)
• Dose : 25ml on each side
• Device to be used: Ultrasound Siemens® ACUSON X300 portable scanner with a high-frequency linear transducer (10 MHz) that is covered in sterile plastic.
• Needle to be used : A Quincke 22 G . x 3½ inch (0.7x88 mm) spinal needle

Intervention Type: PROCEDURE

Other Intervention Names

Modified throacoabdominal plane block (M-TAPA); GROUP A; External Oblique Intercoastal Plane Block ( EOIPB ); GROUP B

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-65 years
• Scheduled for Laparoscopic cholecystectomy surgery
• ASA (American Society of Anaesthesiologists) physical status I-II

Exclusion Criteria

• Known allergy to local anaesthetics
• Coagulopathy or anticoagulant use
• Infection at the site of block
• Chronic pain conditions
• Advanced liver or kidney failure
• History of abdominal surgery or trauma
• Alcohol or drug use
• Refusal to participate
• Chronic opioid consumption
• Use of painkillers in the preoperative 24hours
• Conversion to open surgery
• Body mass index ( BMI ) > 35

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Miran Mohamed Abdelmagyd

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculity of medicine , Kasr Al Aini Hospitals , Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Miran M Abdelaziz Raslan, MSC

Role: CONTACT

miranrs1994@gmail.com

00201140646969

Nora A Agiza, MD

Role: CONTACT

noraagiza@gmail.com

00201001881060

Facility Contacts

Nora A Agiza, MD

Role: primary

noraagiza@gmail.com

00201001881060

References

Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.

Reference Type: BACKGROUND

PMID: 36307755 (View on PubMed)

Other Identifiers

MD-462-2024

Identifier Type: -

Identifier Source: org_study_id