Transversalis Fascia Plane Block Versus M-TAPA Block After Laparoscopic Inguinal Hernia Repair

NCT07619053 | Not Yet Recruiting

• 1 other identifier: TFPB vs M-TAPA/İNG.HERNİA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Transversalis Fascia Plane Block (TFPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic inguinal hernia repair. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block-related complications and adverse effects (hematoma, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.

Conditions

Transversalis Fascia Plane Block; Mtapa Block; Regional Anaesthesia; Postoperative Pain; Laparoscopic Inguinal Hernia Repair

Keywords

TFPB; M-TAPA; İNGUİNAL HERNİA; TRANSVERSALİS FASCİA PLANE BLOCK

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity (VAS score)

  Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

  0, 1, 4, 8, 12, and 24 hours after surgery

Secondary Outcomes (6)

• Total opioid consumption via patient-controlled analgesia (PCA)

  Within the first 24 hours postoperatively

• Requirement for rescue analgesia

  Within the first 24 hours postoperatively

• Potential Complications

  Within the first 24 hours postoperatively

• Patient satisfaction

  At 24 hours postoperatively

• Quality of recovery assessed using the QoR-15 questionnaire

  At 24 hours postoperatively

Study Arms (2)

TRANSVERSALİS FASCİA PLANE BLOCK

ACTIVE COMPARATOR

Procedure: Transversalis Fascia Plane Block

M-TAPA BLOCK

ACTIVE COMPARATOR

Procedure: M TAPA block

Interventions

Transversalis Fascia Plane Block PROCEDURE

A high-frequency linear ultrasound probe will be positioned transversely above the iliac crest along the midaxillary line.Anatomical landmarks, including the external oblique muscle, internal oblique muscle, transversus abdominis muscle, and transversalis fascia will be identified. Using an in-plane approach, a 21 G 0.8×100 mm echogenic insulated needle will be advanced through the muscular layers toward the plane between the transversus abdominis muscle and the transversalis fascia.Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating hydrodissection within the transversalis fascia plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

TRANSVERSALİS FASCİA PLANE BLOCK

M TAPA block PROCEDURE

A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage. Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

M-TAPA BLOCK

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• ASA physical status I-III
• Scheduled for elective laparoscopic inguinal hernia repair
• Body mass index (BMI) 18-35 kg/m²
• Ability to understand and use the patient-controlled analgesia (PCA) device
• Ability to provide written informed consent

You may not qualify if:

• Refusal to participate
• Allergy to local anesthetics
• Infection at the injection site
• Coagulopathy or ongoing anticoagulant therapy
• Chronic opioid use or opioid dependence
• Severe hepatic or renal insufficiency
• Pregnancy or breastfeeding
• Cognitive impairment or inability to communicate pain scores
• Body mass index (BMI) \>35 kg/m²

Sponsors & Collaborators

• Antalya City Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

ENES ESKİN, CONSULTANT İN ANESTHESİOLOGY

CONTACT

+905454738489; eneskin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONSULTANT ANESTHESİOLOGİST

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share