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Comparison of TAP Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery

31 de agosto de 2026 actualizado por: Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Comparison of Transversus Abdominis Plane Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery: A Prospective Randomized Controlled Trial

The aim of this prospective randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided transversus abdominis plane (TAP) block and umbilical paramedian linea semilunaris block in pediatric patients undergoing elective laparoscopic abdominal surgery.

A total of 56 pediatric patients will be randomly assigned in a 1:1 ratio to receive either a TAP block or a linea semilunaris block after induction of general anesthesia and before the start of surgery. Both blocks will be performed under ultrasound guidance using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total dose limited to 2 mg/kg.

The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first analgesic requirement, additional analgesic requirements, postoperative nausea and vomiting, and block-related complications.

Descripción general del estudio

Descripción detallada

Effective postoperative pain management is an important component of perioperative care in pediatric patients. Inadequately controlled postoperative pain may result in agitation, delayed mobilization, delayed oral intake, prolonged hospitalization, and increased analgesic requirements. Although opioids are commonly used for postoperative analgesia, their use in pediatric patients may be associated with adverse effects such as nausea, vomiting, sedation, respiratory depression, and delayed recovery. Therefore, opioid-sparing multimodal analgesic strategies, including ultrasound-guided regional anesthesia techniques, have become increasingly important in pediatric perioperative care.

The transversus abdominis plane (TAP) block is one of the commonly used abdominal wall blocks in pediatric abdominal surgery. However, its dermatomal distribution may be variable, and adequate analgesia may require bilateral or multiple injections. The linea semilunaris block is a more recently described fascial plane block targeting the anatomical region where the internal oblique and transversus abdominis muscles converge. This approach may allow wider local anesthetic spread and potentially provide effective analgesia for both the lateral abdominal wall and regions closer to the midline. However, clinical evidence regarding the linea semilunaris block remains limited, particularly in pediatric patients.

This prospective, randomized controlled trial will include 56 pediatric patients undergoing elective laparoscopic abdominal surgery. After written informed consent is obtained from a parent or legal guardian, participants will be randomly assigned in a 1:1 ratio using a computer-generated randomization sequence and sequentially numbered, sealed, opaque envelopes.

Following induction of general anesthesia and before the start of surgery, participants will receive one of two ultrasound-guided regional anesthesia techniques. Participants assigned to the linea semilunaris block group will receive an ultrasound-guided linea semilunaris block, whereas participants assigned to the TAP block group will receive an ultrasound-guided transversus abdominis plane block. In both groups, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg. All block procedures will be performed by anesthesiologists experienced in pediatric ultrasound-guided regional anesthesia.

All participants will receive standard general anesthesia and perioperative monitoring. Postoperative pain will be assessed using age-appropriate FLACC or Wong-Baker Faces pain scales at predefined postoperative time points.

The primary outcome of the study will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first analgesic requirement, additional analgesic requirements, postoperative nausea and vomiting, and block-related complications. The study aims to determine whether the linea semilunaris block provides effective postoperative analgesia and reduces opioid requirements compared with the TAP block in pediatric laparoscopic abdominal surgery.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

56

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: Fikret Salik, MD
  • Número de teléfono: +905076214125
  • Correo electrónico: fikretsalik@gmail.com

Ubicaciones de estudio

    • Diyarbakır
      • Diyarbakır, Diyarbakır, Turquía (Türkiye)
        • Dicle University Faculty of Medicine Hospital
        • Contacto:

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

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patients scheduled for elective pediatric laparoscopic abdominal surgery
  • Age within the specified eligibility range
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Written informed consent provided by a parent or legal guardian
  • Adequate ultrasound visualization for the planned regional block
  • No known allergy to bupivacaine or ultrasound gel
  • No coagulopathy
  • No infection at the block injection site
  • No previous surgery at the block injection site
  • No anticipated requirement for postoperative intensive care unit admission

Exclusion Criteria:

  • Refusal of the parent or legal guardian to participate
  • Emergency surgery
  • Inadequate ultrasound visualization
  • Coagulopathy
  • Infection or previous surgery at the block injection site
  • Known allergy to bupivacaine or ultrasound gel
  • Conversion from laparoscopic to open surgery
  • Requirement for postoperative intensive care unit admission
  • ASA physical status III or higher

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: USG Guided Transversus Abdominis Plane Block
Participants randomized to this group will receive an ultrasound-guided transversus abdominis plane (TAP) block after induction of general anesthesia and before the start of surgery. The block will be performed using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.
Following induction of general anesthesia and before the start of surgery, an ultrasound-guided transversus abdominis plane (TAP) block will be performed. After identification of the target fascial plane and confirmation by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.
Experimental: USG Guided Linea Semlunaris Block
Participants randomized to this group will receive an ultrasound-guided umbilical paramedian linea semilunaris block after induction of general anesthesia and before the start of surgery. After identification of the linea semilunaris and confirmation of the target plane by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.
Following induction of general anesthesia and before the start of surgery, an ultrasound-guided umbilical paramedian linea semilunaris block will be performed. The linea semilunaris will be identified under ultrasound guidance, and the appropriate fascial plane will be confirmed by hydrodissection. Subsequently, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total Postoperative Opioid Consumption During the First 24 Hours
Periodo de tiempo: First 24 hours after surgery
Total opioid consumption administered for postoperative analgesia will be recorded during the first 24 hours after surgery.
First 24 hours after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Scores
Periodo de tiempo: At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively
Postoperative pain intensity will be assessed using age-appropriate pain assessment scales (FLACC or Wong-Baker Faces Pain Rating Scale).
At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively

Colaboradores e Investigadores

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

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)

25 de agosto de 2026

Finalización primaria (Estimado)

15 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

31 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2026

Publicado por primera vez (Actual)

3 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

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

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared.

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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