Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy (QIPB RCT)
Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial
This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy.
Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.
Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.
All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Engin ihsan Turan, principal investigator
- Número de teléfono: +905382431114
- Correo electrónico: drenginihsan@gmail.com
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34303
- Reclutamiento
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Contacto:
- Engin ihsan Turan
- Número de teléfono: 05382431114
- Correo electrónico: enginihsan@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 75 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
- Planned surgery under general anesthesia
- Able to provide written informed consent
Exclusion Criteria:
- Allergy or hypersensitivity to local anesthetics
- Coagulopathy or active anticoagulant use
- Infection, scar tissue, or skin lesion at the injection site
- Pregnancy or breastfeeding
- Chronic pain syndrome or regular opioid use
- American Society of Anesthesiologists physical status IV or higher
- Planned surgery for two or more levels of disc herniation
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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Comparador activo: Quadro-Iliac Plane Block Group
Participants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia.
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Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position.
After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side.
All participants will receive postoperative fentanyl-based patient-controlled analgesia.
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Comparador activo: Local Infiltration Analgesia Group
Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia.
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Local infiltration analgesia will be performed by the surgeon before the end of surgery.
A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue.
All participants will receive postoperative fentanyl-based patient-controlled analgesia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Fentanyl Consumption During the First 24 Hours After Surgery
Periodo de tiempo: Postoperative 0-24 hours
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Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
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Postoperative 0-24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Pain Scores at Rest and During Movement
Periodo de tiempo: Postoperative 0, 1, 6, 12, and 24 hours
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Pain intensity will be assessed using the Numerical Rating Scale at rest and during movement.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Postoperative 0, 1, 6, 12, and 24 hours
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Opioid-Related Adverse Effects
Periodo de tiempo: Postoperative 0-24 hours
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Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded.
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Postoperative 0-24 hours
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Dermatomal Sensory Spread
Periodo de tiempo: Postoperative 2 hours
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Dermatomal sensory spread of the block will be evaluated using a cold test.
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Postoperative 2 hours
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Number of Patients Require Rescue Analgesic
Periodo de tiempo: Postoperative 0-24 hours
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The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period.
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Postoperative 0-24 hours
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Quality of Recovery Score
Periodo de tiempo: Postoperative 24 hours
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Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire (0-150).
Higher value means better Quality of Recovery.
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Postoperative 24 hours
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Colaboradores e Investigadores
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Quadroiliac plane block RCT
Plan de datos de participantes individuales (IPD)
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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.
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