Skip to main content
OpenTrials
Completed

NCT Number: NCT07403682

M-TAPA vs ESPB for Postoperative Analgesia After Laparoscopic Cholecystectomy

Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects.

The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited.

This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Cholecystectomy, Laparoscopic Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB).

Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias.

All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation.

Postoperative pain intensity will be assessed using the numerical rating scale (NRS) at 0, 1, 6, 12, and 24 hours after surgery. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded.

The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18-65 years
  • ASA physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Ability to understand the study procedures and provide written informed consent

Exclusion criteria

  • Refusal to participate
  • Known allergy to local anesthetics
  • Coagulation disorders or anticoagulant therapy
  • Infection at the injection site
  • Severe hepatic, renal, or cardiac disease
  • Chronic opioid use

Treatment and study plan

Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)

Procedure

An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Erector spinae plane block (ESPB)

Procedure

An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Primary outcomes

  1. Total Opioid Consumption in the First 24 Hours

    Time frame: within the first 24 hours postoperatively

    Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.

Secondary outcomes

  1. Pain intensity at rest (NRS)

    Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively

    Postoperative pain intensity at rest assessed using the Numerical Rating Scale (NRS).

  2. Pain intensity during movement (NRS)

    Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively

    Postoperative pain intensity during movement assessed using the Numerical Rating Scale (NRS).

  3. Rescue analgesic requirement

    Time frame: Within the first 24 hours postoperatively

    Number of patients requiring rescue analgesic medication.

  4. Postoperative nausea and vomiting (PONV)

    Time frame: At postoperative hours 0, 6, 12, and 24

    Incidence of postoperative nausea and vomiting assessed by a blinded observer using a five-point verbal descriptive scale

  5. Time to first rescue analgesia

    Time frame: Within the first 24 hours postoperatively

    Time from the end of surgery to the first administration of rescue analgesic medication.

  6. Quality of recovery (QoR-15)

    Time frame: Postoperative 24 hours

    Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire.

  7. Patient satisfaction

    Time frame: Postoperative 24 hours

    Patient satisfaction with postoperative analgesia assessed using a 10-point numerical rating scale.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Comparison of M-TAPA and ESPB Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.