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

April 4, 2026 updated by: Emre Yilmaz, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total analgesic consumption in 24 hours
Time Frame: 24 hours postoperative
Total amount of dexketoprofen consumed in the first 24 hours after surgery
24 hours postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity (VAS Score)
Time Frame: 0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative
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 Frame: Within 24 hours postoperative
Time from the end of surgery to the first request for analgesic medication
Within 24 hours postoperative
Tramadol Consumption
Time Frame: 24 hours postoperative
Total amount of tramadol administered within the first 24 hours after surgery.
24 hours postoperative
Patient Satisfaction Score
Time Frame: 24 hours postoperative
Patient satisfaction assessed using a Likert scale evaluating overall satisfaction with postoperative pain management
24 hours postoperative
Incidence of Postoperative Nausea and Vomiting
Time Frame: 24 hours postoperative
Incidence of nausea and vomiting observed during the first 24 hours after surgery.
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tahsin Simsek, MD, Kartal Dr. Lutfi Kirdar City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-KAEK-43 (Other Identifier: ISTANBUL PROVINCIAL DIRECTORATE OF HEALTH KOŞUYOLU HIGH SPECIALIZATION EDUCATION AND RESEARCH HOSPITAL ETHİCS COMMİTTEE)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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