NCT06934772

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 5, 2025

Last Update Submit

April 12, 2025

Conditions

Keywords

perioperative pain managementM-TAPA blockperipheral plane blockpain management, bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Analgesic Efficacy

    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 Outcomes (1)

  • Other conditions associated with the block

    postoperative 24 hours

Study Arms (2)

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

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

Interventions

M-TAPAOTHER

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).

M-TAPA Group

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

Eligibility Criteria

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

You may qualify if:

  • patients with a BMI greater than 35 kg/m²,
  • aged between 18 and 65, who are scheduled to undergo LSG surgery.

You may not qualify if:

  • patients with incomplete data
  • patients with chronic pain
  • patients with preoperative opioid use
  • patients with preoperative alcohol/substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (1)

  • Turunc E, Dost B, Sarikaya Ozel E, Kaya C, Ustun YB, Bilgin S, Ozbalci GS, Koksal E. Bilateral Ultrasound-Guided External Oblique Intercostal Block Vs. Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Randomized Controlled Study. Obes Surg. 2024 Oct;34(10):3726-3734. doi: 10.1007/s11695-024-07454-4. Epub 2024 Sep 11.

    PMID: 39259439BACKGROUND

MeSH Terms

Conditions

Bites and StingsAgnosia

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer doctor

Study Record Dates

First Submitted

April 5, 2025

First Posted

April 18, 2025

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 15, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations