Comparison of the Analgesic Efficacy of Subcostal TAP and M-TAPA Blocks in Laparoscopic Sleeve Gastrectomy Surgery

April 12, 2025 updated by: Munevver Kayhan, Haseki Training and Research Hospital

Comparison of the Analgesic Efficacy of Subcostal Transversus Abdominis Plane and Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Blocks in Laparoscopic Sleeve Gastrectomy Surgery

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a Body mass index (BMI) greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

Study Design This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a BMI greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

Study Procedures Patients who meet the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.

Outcome Measures

  • Primary Outcome: Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods (first 24 hours).
  • Secondary Outcomes: Resting and active NRS pain scores, mobilization times, incidence of nausea and vomiting, and complications related to the block procedures.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sultangazi
      • Istanbul, Sultangazi, Turkey, 34265
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a body mass index (BMI) >35 kg/m², Charlson comorbidity index <4, who had received either a subcostal TAP or M-TAPA block after induction but prior to laparoscopic sleeve gastrectomy surgery were included.

Description

Inclusion Criteria:

  • patients with a BMI greater than 35 kg/m²,
  • aged between 18 and 65, who are scheduled to undergo LSG surgery.
  • Patients will receive either a subcostal TAP or M-TAPA block before surgery. Exclusion Criteria:
  • patients with incomplete data
  • patients with chronic pain
  • patients with preoperative opioid use
  • patients with preoperative alcohol/substance use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
M-TAPA Group
Patients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.
Other: M-TAPA
this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).
Subcostal TAP Group
Patients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.
Other: Subcostal TAP
this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Efficacy
Time Frame: Intraoperative periods, postoperative first 24 hours.
Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods.The visual pain score includes values between 0 and 10. o means no pain, 5 means moderate pain, and 10 means severe pain. In the postoperative period, the pain levels of the patients will be compared by looking at this visual pain value. In the intraoperative period, the amount of analgesic consumption (total consumption of remifentanil mcg) will be evaluated.
Intraoperative periods, postoperative first 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other conditions associated with the block
Time Frame: postoperative 24 hours
Resting and active NRS pain scores, mobilization times, nausea and vomiting frequency and complications related to block procedures. Visual pain scores of patients when they first start moving postoperatively will be examined. 0 is evaluated as no pain, 5 as moderate pain, 10 as very severe pain. The time they first started mobilizing will be determined according to the postoperative hour. It will be recorded as whether nausea and vomiting occurred or not. If there were other complications (e.g. bleeding at the block site, hematoma, shortness of breath, pneumothorax), all this information will be determined from the patient files.
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

April 5, 2025

First Submitted That Met QC Criteria

April 12, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HEA-AAR-MK-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Regional Anaesthesia

Clinical Trials on M-TAPA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe