M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery (pain)

December 30, 2025 updated by: Omer Doymus, Erzurum Regional Training & Research Hospital

Comparison of Patient Satisfaction Survey and Pain Follow-up in Patients Who Underwent M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery

Patients will be called to the operating room one hour before surgery and no premedication will be applied before coming to the operating room. Patients in both groups who are taken to the block room will be administered 1-2 mg iv midazolam for sedation. M TAPA block will be applied for the surgical procedure. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. The US probe will be placed in the saggital plane at the costochondral angle where the midclavicular line intersects the costal cartilage. 5 ml of saline will be injected using the in-plane technique using a 22G 100 mm block needle and the block location will be verified. After the block location is verified, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be terminated. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. In TAP block, the block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles with the in-plane technique and the procedure will be completed by injecting 5 ml 20 ml 0.25% bupivacaine unilaterally. The same analgesia protocol will be applied to both groups intraoperatively and postoperatively, and a survey will be conducted on the patients at the 24th hour postoperatively.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
60

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye), 25000
        • Recruiting
        • Erzurum Regional Education and Research Hospital
        • Contact:

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

Exclusion Criteria:

  • History of bleeding diathesis
  • Allergy or sensitivity to local anesthetics and opioids
  • Infection in the area where the block will be applied
  • Alcohol or drug addiction
  • Patients with a BMI > 30
  • Suspected pregnancy
  • Women in pregnancy or lactation
  • Patients with allergies to study drugs
  • Patient refusal
  • Use of anticoagulant agents

Inclusion Criteria:

  • Planning for elective unilateral open inguinal hernia repair surgery
  • ASA I-II status
  • Being between 18 and 65 years of age

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Active Comparator: Group T
The block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles by placing the USG transversely on the mid-axillary line between the iliac crest and subcostal planes. 5 ml saline will be injected and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed.
Procedure: TAP Block Group
20 ml of 0.25% bupivacaine
Active Comparator: Group M
Using the in-plane technique, the probe will be pushed slightly to visualize the lower part of the costochondral angle at the central level, the block needle will be advanced in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage via a 22G 100 mm block needle and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed.
Procedure: M TAPA block
20 ml of 0.25% bupivacaine

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
pain score
Time Frame: The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.
Patients' pain scores will be evaluated
The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.

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
The QoR-15 Patient Questionnaire, a 40-question global recovery rating system with a Turkish variant
Time Frame: 24 hours following surgery.
To compare patient satisfaction survey and pain monitoring in patients who underwent M-Tapa Block and Transversus Abdominal Plane block for postoperative analgesia in unilateral open inguinal hernia repair surgery and to suggest a more effective method.
24 hours following surgery.

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.
Erzurum Regional Training & Research 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.
November 1, 2024

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.
April 1, 2025

Study Completion (Estimated)

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.
January 1, 2026

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).
June 18, 2025

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.
December 30, 2025

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.
December 31, 2025

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.
December 31, 2025

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.
December 30, 2025

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.
June 1, 2025

More Information

Terms related to this study

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.
  • B.30.2.YYU.0.01.00.00/93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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