Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC
Comparison of Analgesic Efficiency in Laparoscopic Percutaneous Extraperitoneal Closure for Pediatric Inguinal Hernia and Hydrocele Provided by Ultrasound Guided Posterior Quadratus Lumborum Block Using Between 0.125% and 0.25% Bupivacaine
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Fifty participants both male and female aged from 1 to 6 years old, AGED FROM 1 TO 6 YEARS OLD, ASA class I to II undergoing elective Laparoscopic percutaneous extraperitoneal closure for pediatric inguinal hernia and hydrocele will be randomly divided into two equal groups of twenty five by using computer generated random table.
All received premedication in the form of midazolam 0.1 mcg/kg IV. Perioperative monitoring included continuous ECG, NIBP and pulse oximetry. Baseline reading of these were recorded. General anesthesia will be inducted using thiopental 5 mg/kg then atracurium 0.5 mg/kg to facilitate endotracheal tube intubation and fentanyl 1 mcg/kg. Anesthesia will be maintained using 2% isoflurane with oxygen to air 40:60.
Posterior quadratus lumborum block (The technique which local anesthetic agent is injected at middle thoracolumbar fascia between erector spina muscle and quadratus lumborum muscle) provided by GE, LOGIQe VERSION (12L-RS, LINEAR ARRAY) ultrasound guided and using stimuplex needle 22G-2 inches on both sides under sterile technique in lateral position will be performed in all patients immediately after induction and before starting surgery. patients will be allocated randomly into two equal groups, twenty five in each as the following GROUP 1 will receive 0.25% bupivacaine 0.4 ml/kg. per each side. GROUP 2 will receive 0.125% bupivacaine 0.4 ml/kg. per each side. The patients and parents along with independent anesthesiologist and attending nurses were not aware of group allocation.
The surgical intervention was started not less than 10 minutes after block. Pneumoperitonium pressure was limited not exceed 10 mmHg. After completion of surgery, anesthesia was discontinued and muscle relaxant was reversed as usual. After extubation, the patients will be transfer to PACU.
Postoperative pain will be assessed by attending nurses, using CHEOPs SCORE. Acetaminophen 10 mg/kg. orally will be given as rescue analgesia for patient with CHEOPs SCORE more than 6. Parameters will be assessed
Intraoperative measurements:
- Hemodynamic parameters: HR and MAP were recorded before, immediately and every 5 minutes after induction of anesthesia until the end of the operation.
- Analgesic requirement: All through the procedure (By measure analgesic need intraoperative in the form of fentanyl 0.5 mcg/kg) In case of increase in intraoperative MAP or HR of more than 20% from baseline.
- Incidence of complications: In the form of hypotension, hematoma, intraabdominal organ injury LAST.
Postoperative measurements:
- Quality of analgesia: Assessed immediately postoperatively every 30 minutes in the PACU and then at 4, 8, 12 hours at ward using CHEOPs SCORE and 24 hours postoperatively using PARENT'S POSTOPERATIVE PAIN MEASUREMENT(PPPM).
- Incidence of complications: In the form assessment of intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability.
- Others: In the form of parent's satisfaction of analgesia and length of hospital stay.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SUWITCHA TAMRONGCHOTE, MD
- Número de teléfono: +66989425629
- Correo electrónico: S.NI.KTAMP@GMAIL.COM
Copia de seguridad de contactos de estudio
- Nombre: NUTTAPHONG LEPANANON, MD
- Número de teléfono: +66850602800
- Correo electrónico: N_PEDIAN@HOTMAIL.COM
Ubicaciones de estudio
-
-
Bangkok
-
Ratchathewi, Bangkok, Tailandia, 10400
- Reclutamiento
- Queen Sirikit National Institute of Child Health
-
Contacto:
- Kullasate Sakpichaisakul, MD
- Correo electrónico: kullasate.s@rsu.ac.th
-
Contacto:
- Kantapon Trongkamolchai, MD
- Correo electrónico: kantapon260619870@gmail.com
-
Investigador principal:
- Kullasate Sakpichaisakul, MD
-
Sub-Investigador:
- Kantapon Trongkamolchai, MD
-
Sub-Investigador:
- Somjit Sri-udomkajorn, MD
-
Sub-Investigador:
- Sirorat Suwannachote, MD
-
Sub-Investigador:
- Ravivan Wittawassamrankul, R Ph
-
Sub-Investigador:
- Ravindra Arya, MD, DM
-
Sub-Investigador:
- Suwitcha Tamrongchote, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
- ASA I-II physical status patients
- Complete inform consent for intervention
Exclusion Criteria:
- Contraindication for regional anesthesia
- Sensitive to local anesthetic agent, opioid or acetaminophen
- Previous history of abdominal surgery
- History of neuromuscular disease
- G6PD deficiency
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: ROUTINE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
|
Comparador activo: ALTERNATIVE DRUG - CONCENTRATION QLB
The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.
|
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of postoperative analgesia
Periodo de tiempo: 24 hours after surgery
|
Postoperative pain score as CHEOPs SCORE
|
24 hours after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of complications
Periodo de tiempo: 12 hours after surgery
|
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
|
12 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: SUWITCHA TAMRONGCHOTE, MD, Queen Sirikit National Institute of Child Health (QSNICH)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC.015/2564
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .
Ensayos clínicos sobre Bupivacaine hydrochloride
-
Indonesia UniversityTerminadoCirugía de Rodilla | Cirugía pélvica | Anestesia espinalIndonesia
-
Recep Tayyip Erdogan Hospital PakistanTerminadoColecistectomía laparoscópica | Analgesia postoperatoria | BupivacaínaPakistán
-
University Hospitals Cleveland Medical CenterReclutamiento
-
Holger JoswigTerminadoHernia de disco lumbar | Hernia de disco cervicalSuiza