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

NCT07595679 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2026-019
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study is designed to evaluate the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal (EOI) plane block on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Abdominal wall blocks are widely used to improve perioperative analgesia; however, their impact on intraoperative opioid requirements when guided by objective nociception monitoring remains unclear. All patients will receive standardized general anesthesia. Intraoperative analgesia will be 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)" will be used to assess nociceptive responses. Remifentanil infusion will be titrated according to SCA values to maintain adequate analgesia. Dose adjustments will be performed at predefined intervals, and changes will be considered valid only if sustained for a minimum duration. Patients will receive either M-TAPA or EOI block as part of routine clinical practice. The choice of block will not be influenced by the investigators, in accordance with the observational design of the study. Data will be collected prospectively during the intraoperative period and postoperative follow-up. The primary outcome of the study is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption (µg/kg), intraoperative hemodynamic parameters (heart rate and mean arterial pressure), frequency of deviations in SCA values from the target range, postoperative pain scores assessed using a numeric rating scale (NRS), time to first analgesic requirement, and total rescue analgesic consumption. Perioperative analgesia will be standardized. All patients will receive intravenous dexketoprofen toward the end of surgery as part of routine clinical practice. Rescue analgesia will be provided with intravenous dexketoprofen when clinically indicated. Additional outcomes include postoperative nausea and vomiting and perioperative complications. This study aims to provide objective data on the opioid-sparing effects of different abdominal wall block techniques when intraoperative analgesia is guided by nociception monitoring. The findings may contribute to optimizing analgesic strategies and improving perioperative pain management in laparoscopic surgery.

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

Patients receiving ePatients receiving modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for intraoperative analgesia during laparoscopic cholecystectomy.ternal oblique intercostal plane block (EOI) for analgesia

EOI Group

Patients receiving external oblique intercostal plane (EOI) block for intraoperative analgesia during laparoscopic cholecystectomy.

Eligibility Criteria

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

Study Population

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.

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

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

Central Study Contacts

İsmet Uluhan, MD

CONTACT

+905077128389; ismtptlk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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 (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share