External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block in Paediatric Upper Abdominal Surgeries
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Paediatric nerve blocks are increasingly recognized as new standard for managing pain in children. The advantages of regional anesthesia in this population include enhanced operating conditions, expedited recovery of bowel function, and reduced postoperative pain.
The caudal epidural block remains the most used method; however, the external oblique intercostal block, a novel technique involves administering local anesthesia deep to the external oblique muscle at the sixth intercostal space, thereby blocking thoracoabdominal nerves from T6 to T10. This technique offers several advantages, including straightforward anatomy, a single muscle strip that is easily identifiable even in obese patients, a bony backstop, and an easily expandable fascial plane that can accommodate a catheter.
The erector spinae plane block involves injecting local anesthetic into the fascial plane beneath the erector spinae muscle at the tip of the vertebral transverse process. This allows the local anesthetic to spread in the craniocaudal fascial plane.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Belal M Hassan, MBBCH
- Número de teléfono: 00201091397908
- Correo electrónico: Belal.bakr1420@alexmed.edu.eg
Ubicaciones de estudio
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Alexandria, Egipto, 21526
- Reclutamiento
- Alexandria University
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Contacto:
- Belal M Hassan, MBBCH
- Número de teléfono: 00201091397908
- Correo electrónico: Belal.bakr1420@alexmed.edu.eg
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Sub-Investigador:
- Wafaa M Shafshak, MD
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Sub-Investigador:
- Ola M Zanaty, MD
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Sub-Investigador:
- Mohamed W Nassar, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged between 6 and 12 years of both sex.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Patients undergoing upper abdominal surgeries involving upper abdominal incisions.
Exclusion Criteria:
- Guardian refusal.
- Allergy to local anesthetics.
- Surgical procedures exceeding 3 hours.
- Infection at the area planned for the block injection.
- Prolonged opioid medication.
- Patients preoperatively medicated by Beta blockers
Plan de estudios
¿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 |
|---|---|
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Experimental: Group I
Patients will receive ultrasound-guided external oblique intercostal plane block.
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Patients will receive ultrasound-guided external oblique intercostal plane block.
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Experimental: Group II
Patients will receive ultrasound-guided erector spinae plane block.
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Patients will receive ultrasound-guided erector spinae plane block.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Degree of pain
Periodo de tiempo: 12 hours after surgery
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Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations. The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain". Children are instructed to select the face that most accurately reflects their current pain level. The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity. |
12 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart rate
Periodo de tiempo: Every 15 minutes intraoperative
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Heart rate will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
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Every 15 minutes intraoperative
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Mean arterial blood pressure
Periodo de tiempo: Every 15 minutes intraoperative
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Mean arterial blood pressure will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
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Every 15 minutes intraoperative
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Peripheral oxygen saturation
Periodo de tiempo: Every 15 minutes intraoperative
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Peripheral oxygen saturation will be recorded preoperative basal readings, after induction of anesthesia, during skin incision, and every 15 minutes intraoperative.
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Every 15 minutes intraoperative
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Duration of analgesia
Periodo de tiempo: 12 hours after surgery
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Duration of analgesia will be recorded from block completion till first postoperative rescue analgesia requirement.
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12 hours after surgery
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Total rescue analgesia requirement
Periodo de tiempo: 12 hours after surgery
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In Faces Pain Scale score-revised, cut of points for analgesic requirement is ≧ 4, rescue analgesia will be administered in the form of nalbuphine 0.1 mg/kg, with a maximum dose of 0.2 mg/kg.
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12 hours after surgery
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Incidence of complications
Periodo de tiempo: 12 hours after surgery
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Incidence of complications including hematomas block failure, intravascular injection, pneumothorax or injection into the peritoneal cavity, with associated risks of damage to bowel and other abdominal viscera at the block site will be recorded.
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12 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 00012098 (0109306)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
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- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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