TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery (TLIP-RLB-QoR)
Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial
This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption.
Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures.
The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.
Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.
Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.
All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.
The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- Número de teléfono: +201063303791
- Correo electrónico: rehab.mohamed19@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Mohamed Abo Elhassan, MD (candidate)
- Número de teléfono: +201001311044
- Correo electrónico: Aboelhassan@gmail.com
Ubicaciones de estudio
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Asyut, Egipto
- Assiut University Hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients aged 18-65 years
- Male and female patients
- Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
- ASA physical status I-III
- BMI < 35 kg/m²
- Willing to participate and provide informed consent
Exclusion Criteria:
- Patient refusal to participate
- Coagulopathy or anticoagulant therapy
- Infection at the site of block injection
- Known allergy to local anesthetics
- Chronic opioid use (>3 months)
- Severe hepatic, renal, or cardiac dysfunction
- Neurological deficits interfering with pain assessment
- Pregnancy or lactation
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: Thoracolumbar interfascial plane Block Group
Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia.
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Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
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Experimental: Retrolaminar Block Group
Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia.
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Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Periodo de tiempo: 24 hours postoperatively
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Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item patient-reported outcome measure.
Scores range from 0 to 150, with higher scores indicating better postoperative recovery.
The primary endpoint is the QoR-15 score at 24 hours after surgery.
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24 hours postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain intensity using Visual Analog Scale (VAS)
Periodo de tiempo: 30 minutes, 2, 6, 12, and 24 hours postoperatively
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Pain will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
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30 minutes, 2, 6, 12, and 24 hours postoperatively
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Time to first rescue analgesia
Periodo de tiempo: Within 24 hours postoperatively
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Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
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Within 24 hours postoperatively
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Total nalbuphine consumption
Periodo de tiempo: 24 hours postoperatively
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Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
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24 hours postoperatively
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Time to first ambulation
Periodo de tiempo: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
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From end of surgery to first ambulation, assessed up to 48 hours postoperatively
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Time to tolerate oral intake
Periodo de tiempo: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
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From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
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Length of hospital stay
Periodo de tiempo: From surgery until hospital discharge, assessed up to 7 days postoperatively
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From surgery until hospital discharge, assessed up to 7 days postoperatively
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Incidence of postoperative complications
Periodo de tiempo: Within 24-48 hours postoperatively
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Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
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Within 24-48 hours postoperatively
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TLIP-RLB-QoR-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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