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EOI Block vs. TAP Block in Minimally Invasive Hepatectomy (EOIvsTAP)

4 de junio de 2026 actualizado por: Hyun-Kyu Yoon, Seoul National University Hospital

External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in Minimally Invasive Hepatectomy: Non-inferiority Trial

This study aims to compare the analgesic efficacy of two different ultrasound-guided nerve blocks-the External Oblique Intercostal (EOI) block and the Subcostal Transversus Abdominis Plane (TAP) block-in patients undergoing minimally invasive hepatectomy. All participants will receive standardized general anesthesia and perioperative care at Seoul National University Hospital. Following anesthesia induction, patients will be randomly assigned to receive either an EOI block or a subcostal TAP block with 0.375% ropivacaine to provide regional pain relief. Postoperative pain will be managed using a combination of scheduled non-opioid analgesics and a fentanyl-based patient-controlled analgesia (PCA) device. The primary objective is to evaluate which regional technique more effectively reduces cumulative opioid consumption during the first 24 hours after surgery. Additionally, the study will assess pain intensity using the Numerical Rating Scale (NRS), the incidence of postoperative nausea and vomiting, and the overall recovery profile, including the time to first ambulation.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

[Anesthesia and Induction] Except for the specific nerve block technique assigned to each group, all participants will receive the standard anesthetic care for minimally invasive hepatectomy at Seoul National University Hospital. No premedication will be administered before entering the operating room, where standard non-invasive monitoring will be established. Anesthesia will be induced with remifentanil target-controlled infusion, propofol, and rocuronium after loss of consciousness. Endotracheal intubation will be performed after neuromuscular blockade. Anesthesia will be maintained with desflurane and remifentanil infusion, adjusted according to clinical requirements. As a part of the perioperative care, palonosetron (0.075 mg) and dexamethasone (5 mg) will be given intravenously during induction for antiemetic prophylaxis, and intravenous acetaminophen (1 g) and nefopam (20 mg) will be administered before the start of surgery. [Interventional Procedures] Following the induction of anesthesia, all nerve blocks will be performed under ultrasound guidance using a high-frequency convex probe covered with a sterile sheath under aseptic conditions. For the External Oblique Intercostal (EOI) block group, the T10 rib will be located at the intersection of the midclavicular line and the umbilical line, and the clinician will count upwards to identify the T6, T7, and T8 ribs. The probe will then be placed perpendicular to the rib trajectory at the T6-7 or T7-8 intercostal space to identify the external intercostal plane. Using an in-plane approach with an 8-cm needle, the plane will be confirmed via hydrodissection with 1-2 mL of saline, followed by the bilateral injection of 20 mL of 0.375% ropivacaine per side (total 40 mL). In contrast, for the Subcostal Transversus Abdominis Plane (TAP) block group, the probe will be placed on the subxiphoid midline and moved laterally along the T12 rib to identify the transversus abdominis plane. The needle will be advanced to the plane between the internal oblique and transversus abdominis muscles, and similarly, 20 mL of 0.375% ropivacaine will be injected into each side (total 40 mL) after confirming the plane with saline. [Postoperative Analgesia and Outcomes] Postoperative pain will be managed primarily using a fentanyl-based patient-controlled analgesia (PCA) device (Accumate 1200, Woo Young Medical), set with a loading dose of 50 mcg, a demand-only bolus of 20 mcg, and a 10-minute lockout time without basal infusion. A scheduled non-opioid regimen, consisting of intravenous acetaminophen (1 g) and nefopam (20 mg) every 8 hours, will be maintained for 48 hours, transitioning to oral acetaminophen (650 mg) once oral intake resumes. In the Post-Anesthesia Care Unit (PACU), if a patient reports a Numerical Rating Scale (NRS) score of 7 or higher despite active PCA use (exceeding four times per hour), a rescue dose of 50 mcg of intravenous fentanyl will be provided.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

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: Hyun-Kyu Yoon
  • Número de teléfono: +82-2-2072-2467
  • Correo electrónico: warren83@snu.ac.kr

Copia de seguridad de contactos de estudio

  • Nombre: wooyoung jo
  • Número de teléfono: 01079333021
  • Correo electrónico: jowoo345@naver.com

Ubicaciones de estudio

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:

Scheduled to undergo elective robotic or laparoscopic minimally invasive hepatectomy

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV or higher
  • History of chronic pain or current use of analgesics, antidepressants, or anticonvulsants for pain management
  • Known hypersensitivity to general anesthetics, opioids, or local anesthetics
  • Conversion to open hepatectomy
  • Requirement for mechanical ventilation for more than 2 hours within 48 hours postoperatively
  • Any other clinical condition that makes the patient unsuitable for participation in the study.

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: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: External Oblique Intercostal (EOI) block group
patients who receive EOI block
Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral external intercostal fascial plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the plane between the external intercostal muscle and the internal intercostal muscle at the T6-7 or T7-8 level.
Comparador activo: Transversus Abdominis Plane (TAP) block group
Patients who receive TAP block
Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral subcostal transversus abdominis plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the fascial plane between the internal oblique and transversus abdominis muscles along the subcostal margin.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative opioid consumption at 24 hours postoperatively
Periodo de tiempo: From the end of surgery up to 24 hours postoperatively
The total amount of intravenous fentanyl administered via patient-controlled analgesia (PCA) and as rescue boluses will be recorded and converted to intravenous morphine equivalents for standardized comparison.
From the end of surgery up to 24 hours postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively
Periodo de tiempo: 1, 6, 12, and 48 hours after surgery completion.
Total amount of fentanyl administered via IV-PCA and rescue boluses. All doses will be recorded and analyzed at each specified time point.
1, 6, 12, and 48 hours after surgery completion.
Postoperative pain intensity measured by Numerical Rating Scale (NRS)
Periodo de tiempo: During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
Pain intensity is assessed using a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable."
During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
Total dose of intraoperative remifentanil
Periodo de tiempo: During the intraoperative period (from induction to skin closure).
Total administered dose of intraoperative remifentanil (mcg) measured from anesthesia induction to skin closure.
During the intraoperative period (from induction to skin closure).
Incidence of Postoperative Nausea and Vomiting
Periodo de tiempo: Up to 48 hours postoperatively.
The presence or absence of postoperative nausea and vomiting episodes (dichotomous outcome: yes/no) will be recorded.
Up to 48 hours postoperatively.
Time to first ambulation
Periodo de tiempo: From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
The time interval (hours) from the end of surgery until the patient first successfully achieves independent or assisted walking.
From the end of surgery up to 48 hours postoperatively (or until the first occurrence).

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Hyun-Kyu Yoon, MD/PhD, Seoul National University Hospital

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)

1 de junio de 2026

Finalización primaria (Estimado)

31 de mayo de 2027

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

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

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2512-081-1703

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Deidentified individual participant data and a data dictionary will be made available to researchers for specified analyses upon reasonable request to the corresponding author via email.

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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