Modified Thoracoabdominal Plane Block and Rectus Block Combination

April 14, 2025 updated by: Ali Hüseyin Demir, Haseki Training and Research Hospital

Comparison of Pain Between Modified Thoracoabdominal Plane Block and Rectus Block Combination and Intraperitoneal Local Infiltration Analgesia

The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

Description

Inclusion Criteria:

  • Over 18 years old
  • ASA1-2
  • Laparoscopic cholecystectomy cases

Exclusion Criteria:

  • Bleeding disorders
  • Anticoagulant use
  • Patients with previous nerve damage
  • Lack of patient consent
  • Patients with liver and kidney failure
  • Patients allergic to local anesthetics used
  • Patients with BMI > 35

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block
Procedure: regional anestesia
Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia
Active Comparator: local infiltration analgesia
Procedure: regional anestesia
Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 4 month
Pain score measured using a 0-10 scale, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
4 month

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 (Estimated)

April 10, 2025

Primary Completion (Estimated)

August 10, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HASEKİ TEZ

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

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.

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