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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Engin ihsan Turan, principal investigator
- Número de telefone: +905382431114
- E-mail: drenginihsan@gmail.com
Locais de estudo
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Istanbul
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Istanbul, Istanbul, Turquia (Türkiye), 34303
- Recrutamento
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Contato:
- Engin ihsan Turan
- Número de telefone: 05382431114
- E-mail: enginihsan@hotmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
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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Comparador Ativo: 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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Fentanyl Consumption During the First 24 Hours After Surgery
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Pain Scores at Rest and During Movement
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Quadroiliac plane block RCT
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