Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Renal Surgeries in Children
19 de mayo de 2022 actualizado por: Kareem Mohammed Assem Nawwar, Cairo University
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Pediatric Open Renal Surgeries: A Randomized Comparative Study.
Open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery & early discharge of patients. Side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use.
Pediatric regional anesthesia (PRA) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. Neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time & hospital stay. Caudal block is the most commonly used neuraxial anesthesia in pediatric patients. However, its major side effect is urinary retention and excessive motor block.
Considerable progress has been made in the practice of PRA over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks.
In this study, the investigators will compare the ultrasound guided quadratus lumborum block (QLB) with erector spinae plane block (ESPB), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. The study hypothesis is that QLB can provide a more superior postoperative pain relief to ESPB in children undergoing open renal surgeries.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
60
Fase
- Fase 4
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: Kareem MA Nawwar, M.D.
- Número de teléfono: +201003878369
- Correo electrónico: drknawwar@cu.edu.eg
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
1 año a 6 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- American society of anesthesiologists (ASA) class I and II
- Children undergoing unilateral open renal surgeries
Exclusion Criteria:
- Parents refusal for the block
- Bleeding disorders (platelets count < 100,000/uL; INR > 1.5; PC < 60%)
- Skin lesion, wounds or infection at the puncture site.
- Known allergy to local anesthetic drugs
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Erector spinae plane block (ESPB) group
30 child will receive a preoperative unilateral single shot US-guided erector spinae plane block at the level of T9 vertebra in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
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Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane deep to erector spinae muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline and observing the fluid lifting the erector spinae muscle off the transverse process (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the spinous process on a parasagittal plane, to visualize the erector spinae muscle and transverse process, directing the needle craniocaudally using the in-plane technique.
The spread of the injectate will be observed to distribute within this plane.
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
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Comparador activo: Quadratus lumborum block (QLB) group
30 child will receive a preoperative unilateral single shot US-guided quadratus lumborum block at the level of L2 spinous process in the lateral position after induction of general anesthesia, using 0.5 mL/kg of bupivacaine 0.125%
|
Sonosite S-Nerve (USA) with a linear multi-frequency 6-13 MHz (hockey stick) transducer
A 22-gauge 80 mm needle the sonoplex needle manufactured by PAJUNK (USA)
Given intravenously (1 µg/kg) as part of induction of general anesthesia (GA) added to propofol 2 mg/kg and atracurium 0.5 mg/kg Intraoperatively, intravenous fentanyl 0.5 µg/kg (with a maximum dose of 2 µg/kg) will be administered in response to any increase in hemodynamics by more than 20% of baseline values in response to skin incision or there after throughout surgery (after exclusion of other causes of hemodynamic changes)
Will be given intravenously as a rescue analgesic (0.5 mg/kg with maximal dose 1.5 mg/kg) in both study groups if Children's Hospital Eastern Ontario Pain Scale (CHEOPS) more than 6.
Quality of postoperative analgesia will be assessed using CHEOPS pain score at time transfer to PACU, 15, 30 minutes then 1, 2, 4, 6 hours postoperatively.
Using a 22-gauge 80 mm echogenic needle under ultrasound guidance, 0.5 mL/kg of bupivacaine 0.125% will be injected in the fascial plane between the quadratus lumborum and psoas major muscle after confirming correct needle location by a negative aspiration test then by injecting 0.5-1 ml saline (hydrodissection).
The ultrasound probe will be placed 2-3 cm lateral to the L2 spinous process on an axial plane, to visualize the transverse process with psoas major muscle anterior, quadratus lumborum muscle lateral and erector spinae muscle posterior to it.
The needle is inserted from the medial side of the probe and advanced laterally using the in-plane technique.
The spread of the injectate will be observed to distribute within the target plane.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to first postoperative rescue analgesia
Periodo de tiempo: 12 hours
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Time in minutes when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score exceeds 6 for the first time.
Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
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12 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total opioid analgesic consumption in the first 12 hours postoperative period
Periodo de tiempo: from time of patient transfer to the PACU, till 12 hours postoperatively
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when postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) pain score ˃ 6 in the first 12 hours postoperatively.
Children's Hospital Eastern Ontario Pain Scale is a pain score with the least possible score is 4, while the highest possible score 13 (worse outcome).
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from time of patient transfer to the PACU, till 12 hours postoperatively
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Intraoperative mean arterial blood pressure
Periodo de tiempo: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
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measured from induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
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During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
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Intraoperative heart rate
Periodo de tiempo: During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
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measured before and after induction of general anesthesia, after performance of the nerve block and at 1,5,10, 15 mins.
after
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During surgery (from induction of general anesthesia till 15 mins. after performance of the nerve block)
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Postoperative pain score
Periodo de tiempo: from time of patient transfer to the PACU, till 12 hours postoperatively
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measured at time of patient transfer to the PACU, 15, 30 mins, 1 ,2 , 4 ,6 ,12 hours after surgery
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from time of patient transfer to the PACU, till 12 hours postoperatively
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Block performance time
Periodo de tiempo: Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
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Time to perform ultrasound guided nerve block
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Time from ultrasound visualization of target injection site to end of local anesthetic (bupivacaine) deposition up to 15 mins.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Indirect signs of local anesthetic toxicity
Periodo de tiempo: from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
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intraoperative arrhythmias and delayed awakening
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from time of local anesthetic (bupivacaine) deposition till 6 hours postoperatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Nevine M Gouda, Cairo University
- Silla de estudio: Sherif M Soaida, Cairo University
- Silla de estudio: Ismail S Hammad, Cairo University
- Investigador principal: Ahmed T Bahnaswy, Cairo University
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 (Anticipado)
20 de mayo de 2022
Finalización primaria (Anticipado)
1 de septiembre de 2022
Finalización del estudio (Anticipado)
15 de septiembre de 2022
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2022
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2022
Publicado por primera vez (Actual)
23 de mayo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Dolor Postoperatorio
- Dolor agudo
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Analgésicos Opiáceos
- Estupefacientes
- Adyuvantes, Anestesia
- Fentanilo
- Meperidina
Otros números de identificación del estudio
- md-13-2022
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
producto fabricado y exportado desde los EE. UU.
No
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