NCT07522853

Brief Summary

This randomized controlled trial aims to compare the postoperative analgesic efficacy of M-TAPA block and OSTAP block in patients undergoing laparoscopic inguinal hernia repair. Pain scores, analgesic consumption, and patient satisfaction will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

April 8, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

Keywords

MTAPAOSTAPPostoperative painTAP BlockVAS Score

Outcome Measures

Primary Outcomes (1)

  • Total analgesic consumption in 24 hours

    Total amount of dexketoprofen consumed in the first 24 hours after surgery

    24 hours postoperative

Secondary Outcomes (5)

  • Postoperative Pain Intensity (VAS Score)

    0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative

  • Time to First Analgesic Requirement

    Within 24 hours postoperative

  • Tramadol Consumption

    24 hours postoperative

  • Patient Satisfaction Score

    24 hours postoperative

  • Incidence of Postoperative Nausea and Vomiting

    24 hours postoperative

Study Arms (3)

M-TAPA

EXPERIMENTAL

Bilateral M-TAPA block applied after surgery

Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)

OSTAP

EXPERIMENTAL

Bilateral OSTAP block applied after surgery

Procedure: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP)

CONTROL

OTHER

No block applied and standart analgesia procedure

Other: Standard Analgesia use (paracetamol, contramal)

Interventions

Ultrasound-guided bilateral OSTAP block performed with 20 mL of 0.25% bupivacaine per side

OSTAP

Ultrasound-guided bilateral M-TAPA block performed with 20 mL of 0.25% bupivacaine per side

M-TAPA

Patients received standard postoperative analgesia without regional block

CONTROL

Eligibility Criteria

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

You may qualify if:

  • Patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective laparoscopic inguinal hernia repair (TEP technique)
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Provided written informed consent

You may not qualify if:

  • Refusal to participate or inability to provide informed consent
  • Age under 18 or over 65 years
  • ASA physical status ≥ III
  • Coagulopathy (including abnormal INR, thrombocytopenia, or platelet dysfunction)
  • Infection at the injection site
  • Known allergy or hypersensitivity to study medications (local anesthetics, NSAIDs, opioids)
  • Chronic opioid use (longer than 4 weeks)
  • Use of psychiatric medications affecting pain perception
  • Inability to cooperate or communicate effectively
  • Requirement for postoperative intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetaminophenTramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Officials

  • Tahsin Simsek, MD

    Kartal Dr. Lütfi Kirdar City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Resident in Anesthesiology and Reanimation

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

April 8, 2025

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to patient confidentiality, ethical considerations, and institutional regulations.

Locations