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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- Número de telefone: +201063303791
- E-mail: rehab.mohamed19@gmail.com
Estude backup de contato
- Nome: Mohamed Abo Elhassan, MD (candidate)
- Número de telefone: +201001311044
- E-mail: Aboelhassan@gmail.com
Locais de estudo
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Asyut, Egito
- Assiut University Hospitals
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity using Visual Analog Scale (VAS)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TLIP-RLB-QoR-2026
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