NCT06925945

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 7, 2025

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    Pain score measured using a 0-10 scale, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

    4 month

Study Arms (2)

Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block

ACTIVE COMPARATOR

Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block

Procedure: regional anestesia

local infiltration analgesia

ACTIVE COMPARATOR

local infiltration analgesia

Procedure: regional anestesia

Interventions

Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia

Modified thoracoabdominal plane block (M-TAPA) and rectus sheath blocklocal infiltration analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.

  • Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.

Central Study Contacts

ALİ HÜSEYİN DEMİR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

April 10, 2025

Primary Completion

August 10, 2025

Study Completion

August 15, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share