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Clinical Trials/NCT07522853
NCT07522853
Completed
Not Applicable

Laparoscopic Inguinal Hernia Surgery Patients: Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Oblique Subcostal TAP Block for Postoperative Analgesia

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 site in 1 country90 target enrollmentStarted: April 8, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Enrollment
90
Locations
1
Primary Endpoint
Total analgesic consumption in 24 hours

Overview

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.

Detailed Description

Prospective, randomized, single-blind, controlled study including 90 patients undergoing elective laparoscopic inguinal hernia repair. Patients will be randomized into three groups: M-TAPA, OSTAP, and control. Postoperative pain scores (VAS), analgesic consumption, time to first analgesic requirement, and patient satisfaction will be assessed over 24 hours.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

M-TAPA

Experimental

Bilateral M-TAPA block applied after surgery

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

OSTAP

Experimental

Bilateral OSTAP block applied after surgery

Intervention: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) (Procedure)

CONTROL

Other

No block applied and standart analgesia procedure

Intervention: Standard Analgesia use (paracetamol, contramal) (Other)

Outcomes

Primary Outcomes

Total analgesic consumption in 24 hours

Time Frame: 24 hours postoperative

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Emre Yilmaz

MD, Resident in Anesthesiology and Reanimation

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study Sites (1)

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