- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311902
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: omer doymus
- Phone Number: +905070370397
- Email: omerdoymus@hotmail.com
Study Locations
-
-
-
Erzurum, Turkey (Türkiye), 25000
- Recruiting
- Erzurum Regional Education and Research Hospital
-
Contact:
- Erzurum RTRH
- Phone Number: +90 ( 442 ) 432 10 00
- Email: erzurumsh@saglik.gov.tr
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
20 ml of 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
November 1, 2024
Primary Completion (Actual)
April 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
June 18, 2025
First Submitted That Met QC Criteria
December 30, 2025
First Posted (Actual)
December 31, 2025
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 30, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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