Official Title
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
Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of theTransversalis Fascia Plane Block (TFPB) and the Modified Thoracoabdominal Nerve Blockthrough Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic inguinalhernia repair. The primary outcome is the Visual Analog Scale (VAS) score within thefirst 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 usingthe 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Patients who meet the exclusion criteria will be withdrawn from the study.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.

All patients will be monitored with electrocardiography, peripheral oxygen saturation
(SpO2), and non-invasive blood pressure prior to the block. Premedication with
intravenous midazolam (0.02 mg/kg) will be administered.

Transversalis Fascia Plane Block (TFPB) The block will be performed 30 minutes prior to
surgery with the patient in the supine position. After skin disinfection with
chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1%
lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey).

A high-frequency linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model
DC-T6) 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 (Echoplex®+, Vygon SA,
Écouen, France) 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 (Buvasin®, Vem
Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.

M-TAPA Block The block will be performed 30 minutes prior to surgery with the patient in
a supine position. After skin disinfection with chlorhexidine, the skin and subcutaneous
tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel
Pharmaceuticals, Turkey).

A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) 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 (Echoplex®+, Vygon SA,
Écouen, France) 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
(Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under
ultrasound guidance.

General Anesthesia Upon entry into the operating room, patients will be monitored with
electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood
pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma
Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg,
Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide
(0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).
Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture
and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation
settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO#
maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a
Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value
of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the
remifentanil dose will be titrated accordingly.

Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of
intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade
Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and
vomiting, 4 mg intravenous ondansetron will be administered. Patients with adequate
spontaneous ventilation will be extubated and transferred to the post-anesthesia care
unit (PACU). Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood
pressure, mean arterial pressure, and oxygen saturation will be recorded at the following
time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after
surgical incision, 15 minutes after incision, and at the end of surgery. Postoperative
Pain and Analgesic Use: Pain will be assessed using the VAS at rest (static) and during
movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively. All patients will use
patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set
to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval.
Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol
will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg)
will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other
analgesics will be recorded. Postoperative Recovery Quality Postoperative recovery will
be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which
evaluates five domains: pain, physical comfort, physical independence, psychological
support, and emotional state. Patient Satisfaction Satisfaction will be evaluated using a
5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal
feedback from both the patient and the surgeon. Nausea and Vomiting: Nausea and vomiting
will be scored using a 4-point scale: 0 = none

1. = mild

2. = moderate

3. = severe Potential Complications Any complications associated with the block or the
surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic
toxicity, vascular puncture, or infection) will be recorded.

Not yet recruiting
Transversalis Fascia Plane Block
Mtapa Block
Regional Anaesthesia
Postoperative Pain
Laparoscopic Inguinal Hernia Repair

Procedure: Transversalis Fascia Plane Block

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.

Procedure: M TAPA block

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Locations

Not Provided

Contacts

ENES ESKİN, CONSULTANT İN ANESTHESİOLOGY
+905454738489
eneskin@hotmail.com

Not Provided

Antalya City Hospital
NCT Number
Keywords
TFPB
m-tapa
İNGUİNAL HERNİA
TRANSVERSALİS FASCİA PLANE BLOCK
MeSH Terms
Pain, Postoperative
Hernia, Inguinal