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

26 de mayo de 2026 actualizado por: Enes Eskin, Antalya City Hospital

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: ENES ESKİN, CONSULTANT İN ANESTHESİOLOGY
  • Número de teléfono: +905454738489
  • Correo electrónico: eneskin@hotmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: TRANSVERSALİS FASCİA 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.
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain intensity (VAS score)
Periodo de tiempo: 0, 1, 4, 8, 12, and 24 hours after surgery
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Requisito de analgesia de rescate
Periodo de tiempo: Durante las primeras 24 horas postoperatorias
Durante las primeras 24 horas postoperatorias
Incidencia de náuseas y vómitos posoperatorios
Periodo de tiempo: Dentro de las primeras 24 horas postoperatorias
Dentro de las primeras 24 horas postoperatorias
Consumo total de opioides mediante analgesia controlada por el paciente (PCA)
Periodo de tiempo: Dentro de las primeras 24 horas postoperatorias
Dentro de las primeras 24 horas postoperatorias
Quality of recovery assessed using the QoR-15 questionnaire
Periodo de tiempo: At 24 hours postoperatively
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
At 24 hours postoperatively
Potential Complications
Periodo de tiempo: Within the first 24 hours postoperatively
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.
Within the first 24 hours postoperatively
Patient satisfaction
Periodo de tiempo: At 24 hours postoperatively

Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4

= satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.

At 24 hours postoperatively

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de noviembre de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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