Comparison of M-TAPA and External Oblique Intercostal Block for Intraoperative Opioid Consumption in Laparoscopic Cholecystectomy

NCT07595679 | Completed

• 1 other identifier: AEŞH-EK-2026-019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Eighty patients are randomized into two groups: the M-TAPA group and the EOI group. All patients receive standardized general anesthesia. Intraoperative analgesia is guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter "peaks per second (PPS)" is used to assess nociceptive responses, and remifentanil infusion is titrated according to SCA values. Patients assigned to the M-TAPA group receive bilateral ultrasound-guided M-TAPA block, while patients assigned to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side. Perioperative analgesia is standardized. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the numeric rating scale (NRS) pain score is 4 or higher. The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, intraoperative hemodynamic parameters, SCA measurements, postoperative pain scores, time to first rescue analgesic requirement, rescue analgesic consumption, postoperative nausea and vomiting, and perioperative complications. The study aims to compare the opioid-sparing and analgesic effects of M-TAPA and EOI under objective nociception-guided intraoperative analgesia.

Conditions

Laparoscopic Cholecystectomy Surgery; Perioperative Analgesia

Keywords

M-TAPA; External Oblique Intercostal Block; Abdominal Wall Block; Skin Conductance Algesimeter; Remifentanil; Opioid Consumption; Laparoscopic Cholecystectomy; Intraoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Time-Weighted Mean Intraoperative Remifentanil Infusion Rate

  The time-weighted mean intraoperative remifentanil infusion rate will be calculated throughout the surgical period and expressed as micrograms per kilogram per minute (µg/kg/min) based on continuous infusion data.

  Intraoperative period (from induction to end of surgery)

Secondary Outcomes (7)

• Postoperative Pain Scores Assessed by Numeric Rating Scale

  0, 2, 4, 6, 12, and 24 hours postoperatively

• Time to First Analgesic Requirement

  Within 24 hours postoperatively

• Rescue Analgesic Consumption

  First 24 hours postoperatively

• Mean Arterial Pressure

  Intraoperative period

• Heart Rate

  Intraoperative period

Study Arms (2)

M-TAPA Group

EXPERIMENTAL

Patients assigned to this arm received bilateral modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for perioperative analgesia during laparoscopic cholecystectomy.

Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)

EOI Group

ACTIVE COMPARATOR

Patients assigned to this arm received bilateral external oblique intercostal plane block (EOIPB) for perioperative analgesia during laparoscopic cholecystectomy.

Procedure: External Oblique Intercostal Plane Block (EOI)

Interventions

External Oblique Intercostal Plane Block (EOI) PROCEDURE

Patients received bilateral ultrasound-guided external oblique intercostal plane block (EOI). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy.

Also known as: EOI

EOI Group

Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) PROCEDURE

Patients received bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA). A total of 20 mL of 0.25% bupivacaine was administered on each side for perioperative analgesia during laparoscopic cholecystectomy.

Also known as: M-TAPA

M-TAPA Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years
• ASA physical status I-III
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Ability to provide written informed consent

You may not qualify if:

• Patient refusal
• Known allergy to local anesthetics
• Chronic opioid use or opioid dependence
• Neurological or psychiatric disorders affecting pain perception
• Use of medications affecting autonomic nervous system activity, such as beta-blockers
• Infection at the injection site
• Coagulopathy or anticoagulant therapy
• Pregnancy

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara etlik city hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Location

Related Publications (3)

• Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4.

  PMID: 39891061 BACKGROUND

• Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.

  PMID: 34626112 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

  PMID: 30639940 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start: May 15, 2026
• Primary Completion: August 31, 2026
• Study Completion: September 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)