Bloqueo del Plano Interfascial Cuadro-Ilíaco vs Toracolumbar para Analgesia Después de Cirugía de Disco Lumbar de un Solo Nivel
Comparación de la Eficacia Analgésica Postoperatoria del Bloqueo del Plano Cuadro-Ilíaco y del Bloqueo Clásico del Plano Interfascial Toracolumbar en la Cirugía de Disco Lumbar de Nivel Único: Un Ensayo Controlado Aleatorizado Prospectivo
The investigators aim to compare the postoperative analgesic efficacy of the classical thoracolumbar interfascial plane block and the Quadro-iliac plane block for postoperative analgesia management after lumbar disc surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Lumbar spinal stenosis can lead to variable signs and symptoms such as back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques can reduce opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
For patients undergoing lumbar disc surgery, the classical thoracolumbar interfascial plane (TLIP) block and the Quadro-iliac plane block (QIPB) provide effective analgesia for postoperative pain control.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Samsun, Turquía (Türkiye)
- Samsun University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Exclusion Criteria:
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
- Inability to use a patient-controlled analgesia (PCA) device
- Suspected pregnancy, confirmed pregnancy, or breastfeeding
- Refusal to undergo the procedure or to participate in the study
Plan de estudios
¿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 |
|---|---|
|
Otro: Active Comparator: Group QİPB
The Quadro-iliac plane block will be performed 30 minutes before lumbar spine surgery |
Quadro-iliac plane block will be performed under ultrasound guidance before the induction of general anesthesia. |
|
Otro: Active Comparator: Group TLİP
The classical thoracolumbar interfascial plane (TLIP) block will be performed 30 minutes before lumbar spine surgery. |
Classical thoracolumbar interfascial plane block will be performed under ultrasound guidance before the induction of general anesthesia. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Opioid consumption
Periodo de tiempo: 24 hours
|
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups. |
24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perioperative pain intensity
Periodo de tiempo: 24 hours
|
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain'). |
24 hours
|
|
Postoperative nausea and vomiting
Periodo de tiempo: 24 hours
|
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting). |
24 hours
|
|
Quality of recovery 15 scale
Periodo de tiempo: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale. The QoR-15 (Quality of Recovery-15) questionnaire is a simple and practical tool used to assess postoperative recovery. It consists of 15 items, each scored on a numeric scale from 0 to 10, resulting in a total score ranging from 0 to 150. Based on the total score, postoperative recovery is categorized as follows: 136-150: Excellent recovery 122-135: Good recovery 90-121: Moderate recovery 0-89: Poor recovery |
24 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hale KEFELI CELIK, M.D., Samsun University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- OMUKAEK 2025/279
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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