Transversalis Fascia Plane Block Versus Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Inguinal Hernia Repair: A Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
Study Overview
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.
Detailed Description
Study Objective This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Transversalis Fascia Plane Block (TFPB) and M-TAPA Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic inguinal hernia repair. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Materials and Methods This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) 18-35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.
Study Groups and Block Procedures
Group TFP Group TFP will receive a bilateral Transversalis Fascia Plane Block. Group M-TAPA Group M-TAPA will receive a bilateral M-TAPA block.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Enes Eskin
CONSULTANT ANESTHESİOLOGİST
Antalya City Hospital