M-TAPA vs OSTAP for Postoperative Analgesia in Laparoscopic Inguinal Hernia

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Inguinal Hernia Bilateral
• Intervention / Treatment: Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA); Procedure: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP); Other: Standard Analgesia use (paracetamol, contramal)

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M-TAPA; Bilateral M-TAPA block applied after surgery	Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA); Ultrasound-guided bilateral M-TAPA block performed with 20 mL of 0.25% bupivacaine per side
Experimental: OSTAP; Bilateral OSTAP block applied after surgery	Procedure: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP); Ultrasound-guided bilateral OSTAP block performed with 20 mL of 0.25% bupivacaine per side
Other: CONTROL; No block applied and standart analgesia procedure	Other: Standard Analgesia use (paracetamol, contramal); Patients received standard postoperative analgesia without regional block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic consumption in 24 hours	Total amount of dexketoprofen consumed in the first 24 hours after surgery	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity (VAS Score)	Postoperative pain intensity assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.	0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative
Time to First Analgesic Requirement	Time from the end of surgery to the first request for analgesic medication	Within 24 hours postoperative
Tramadol Consumption	Total amount of tramadol administered within the first 24 hours after surgery.	24 hours postoperative
Patient Satisfaction Score	Patient satisfaction assessed using a Likert scale evaluating overall satisfaction with postoperative pain management	24 hours postoperative
Incidence of Postoperative Nausea and Vomiting	Incidence of nausea and vomiting observed during the first 24 hours after surgery.	24 hours postoperative

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: Tahsin Simsek, MD, Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; TAP Block; MTAPA; OSTAP; VAS Score
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Lipids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Acetaminophen; Tramadol
• Other Study ID Numbers: 2025-KAEK-43 (ISTANBUL PROVINCIAL DIRECTORATE OF HEALTH KOŞUYOLU HIGH SPECIALIZATION EDUCATION AND CLINICAL RESEARCH ETHICS COMMITTEE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient confidentiality, ethical considerations, and institutional regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No