NCT07311902

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 31, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 18, 2025

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain score

    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 Outcomes (1)

  • The QoR-15 Patient Questionnaire, a 40-question global recovery rating system with a Turkish variant

    24 hours following surgery.

Study Arms (2)

Group T

ACTIVE COMPARATOR

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

Group M

ACTIVE COMPARATOR

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

Interventions

20 ml of 0.25% bupivacaine

Group T
M TAPA blockPROCEDURE

20 ml of 0.25% bupivacaine

Group M

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Regional Education and Research Hospital

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 18, 2025

First Posted

December 31, 2025

Study Start

November 1, 2024

Primary Completion

April 1, 2025

Study Completion

January 1, 2026

Last Updated

December 31, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations