Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA)

NCT06932835 | Recruiting

• 1 other identifier: AEŞH-EK-2025-043
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain can impair recovery quality and increase the risk of postoperative pulmonary complications as a risk factor for chronic pain development. Multimodal analgesia, including opioids, is used to limit pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation. Nerve blocks provide better pain control, reduce opioid consumption in the postoperative period, and offer advantages such as fewer side effects and a lower risk of pulmonary and cardiac complications. In our clinic, a multimodal analgesia approach is preferred for patients undergoing laparoscopic cholecystectomy. In addition to intravenous analgesic agents, peripheral nerve blocks are administered based on patient preference (for all eligible and consenting patients). This study aims to compare the postoperative analgesic efficacy of the Transversus Abdominis Plane (TAP) Block and the Modified Thoracoabdominal Nerve Block with a Pericostal Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Standard analgesic methods are applied to patients who do not consent to peripheral nerve block administration.

Conditions

Laparoskopic Cholecystectomy; Transversus Abdominis Plane (TAP) Block; Modified Thoracoabdominal Nerve Block (M-TAPA)

Keywords

remifantanile conception; acute pain; Postoperatif pain

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst

  First 24 hours after surgery

Secondary Outcomes (1)

• Intraoperative remifentanil consumption

  During The intraoperatif period

Study Arms (2)

Transversus Abdominis Plane (TAP) Block

ACTIVE COMPARATOR

The patient is placed in the supine position,the injection site is disinfected.The Transversus Abdominis Plane block is performed under ultrasound guidance using a high-frequency linear probe(6-13 MHz)placed sagittally at the midpoint between the costal margin and the iliac crest.On ultrasound, the skin, subcutaneous fat tissue, external oblique muscle, internal oblique muscle, and transversus abdominis muscle are visualized. A 2G, 80 mm block needle is inserted in the same plane as the ultrasound probe.As the needle passes through the muscle layers and fascial planes, a fascial "click" sensation is felt, and the needle tip is advanced under ultrasound guidance in a controlled manner.After the second "click" sensation(the passage through the internal oblique muscle fascia) a test dose of 1 mL is administered to confirm needle tip localization.Once the location is verified, 20 mL of 0.25% bupivacaine is injected into the neurofascial plane. then repeated on the contralateral side.

Drug: Transversus Abdominis Plane (TAP) Block

Modified Thoracoabdominal Nerve Block (M-TAPA)

ACTIVE COMPARATOR

The patient is placed in the supine position, and the injection site is disinfected.Modified Thoracoabdominal Nerve Block To identify the transversus abdominis, internal oblique and external oblique muscles a high-frequency linear ultrasound probe (6-13 MHz) is placed sagittally at the 10th costal margin under USG guidance.After positioning the probe sagittally at the 10th costal margin in the midline, it is angled deeply toward the costochondral angle to visualize the lower costal cartilage.Using an in-plane technique, a 22G, 80 mm block needle is inserted in a cranial direction between the transversus abdominis muscle and the lower surface of the costal cartilage. The needle tip is advanced toward the posterior surface of the 10th costal cartilage, and 20 mL of 0.25% bupivacaine is injected beneath the chondrium while ensuring that the needle tip does not pass beyond the cranial border of the 10th costal cartilage. The same procedure is then repeated on the contralateral side.

Drug: Modified Thoracoabdominal Nerve Block (M-TAPA)

Interventions

Transversus Abdominis Plane (TAP) Block DRUG

Transversus Abdominis Plane (TAP) Block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.

Transversus Abdominis Plane (TAP) Block

Modified Thoracoabdominal Nerve Block (M-TAPA) DRUG

Modified Thoracoabdominal Nerve Block (M-TAPA) is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.

Modified Thoracoabdominal Nerve Block (M-TAPA)

Eligibility Criteria

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

You may qualify if:

• to 65 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• Body mass index 18 to 30 kg/m2
• Elective laparoscopic cholecystectomy surgery

You may not qualify if:

• Under 18 and over 65
• ASA score IV and above
• Advanced co-morbidity
• History of bleeding diathesis
• Patient refusing the procedure
• Chronic opioid or analgesic use
• Patients who will operate under emergency conditions
• Block injection site infection
• Known allergy to local anesthetics
• Pregnancy

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bites and Stings; Acute Pain

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

MÜRÜVVET TAŞKIR TURAN, MD

CONTACT

00905065536934; taskirmuruvvet@gmail.com

MUSA ZENGİN, Associate Professor

CONTACT

00905307716235; musazengin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: June 2, 2025
• Primary Completion: April 11, 2026
• Study Completion: April 21, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TU (1)