NCT06483607

Brief Summary

The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic inguinal hernia surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

June 25, 2024

Last Update Submit

February 9, 2026

Conditions

Keywords

m-tapatap blocklaparoscopic inguinal herniaregional anesthesiapostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Comparing the numerical rating scale scores

    Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

    Postoperative 24 hours

Secondary Outcomes (1)

  • Comparing total tramadol consumption

    Postoperative 24 hours

Study Arms (3)

CONTROL

NO INTERVENTION

Control group patients are not going to be subjected to any block or local infiltration anesthesia. Their postoperative pain will be relieved with ibuprofen and tramadol (intravenous) administrations.

M-TAPA

ACTIVE COMPARATOR

Patients will have bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Other: M-TAPA block with bupivacaine 25%

TAP

ACTIVE COMPARATOR

Patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Other: TAP block with bupivacaine 25%

Interventions

Following sterile conditions for bilateral M-TAPA block application, the transducer will be inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle will be created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip will be placed just below the chondrium and saline (5 ml) will be injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine will be administered for each group for a total of 40 ml of local anesthetic. Blocks will be applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose will be applied to the contralateral side for each group of M-TAPA patients.

Also known as: Modified thoracoabdominal nerve block through perichondrial approach
M-TAPA

After the necessary sterilization conditions established, the linear ultrasound probe will be placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum will be identified. As the tip of the 80 mm sonovisible needle passes through the muscular layers and fascia, the needle will be advanced in a controlled manner. After receiving the click sensation (passage of the fascia of the internal oblique muscle), the location of the needle will be fixed and 20 ml of 0.25% bupivacaine will be injected between internal oblique and transversus abdominis muscles. Same procedure will be performed to the other site. (40 ml local anesthetics in total)

Also known as: Transversus abdominis plane block
TAP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

You may not qualify if:

  • Patients who did not give consent,
  • patients with coagulopathy,
  • patients with signs of infection at the block application site,
  • patients using anticoagulants,
  • patients with local anesthetic drug allergies,
  • patients undergoing open surgery,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Sivas, Si̇vas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Oğuz Gündoğdu

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 3, 2024

Study Start

July 15, 2024

Primary Completion

September 23, 2025

Study Completion

January 17, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations