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- Ensaio Clínico NCT07587320
Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery (BLOCKCABG)
Effect of Induction-Time Multimodal Fascial Plane Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Isolated Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery.
This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting.
Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Median sternotomy, chest drains, and saphenous vein graft harvesting are major contributors to postoperative pain following CABG surgery. Inadequate pain control may impair respiratory mechanics, delay mobilization, and increase postoperative morbidity. Multimodal analgesic approaches aim to reduce opioid requirements and improve recovery profiles.
This single-center, prospective, randomized controlled trial will include adult patients (18-80 years) scheduled for elective isolated CABG with saphenous vein graft harvesting. After written informed consent, eligible participants will be randomly assigned to either the intervention group or the control group.
The intervention group will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and prior to surgical incision. The control group will receive standard perioperative analgesia without regional block. All other perioperative management will be standardized.
The primary endpoint is total opioid consumption within the first 24 hours postoperatively. Secondary endpoints include pain scores at predefined time points (6, 12, 24, and 48 hours), time to first opioid requirement, extubation time, incidence of postoperative pulmonary complications and atrial fibrillation, ICU length of stay, hospital length of stay, and time to first mobilization.
The study is designed to assess whether a multimodal fascial plane block strategy can improve postoperative analgesia and reduce opioid use in cardiac surgery patients.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Selen Topalel, MD
- Número de telefone: +90 533 506 33 20
- E-mail: selentopalel26@gmail.com
Locais de estudo
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Diyarbakır
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Diyarbakır, Diyarbakır, Turquia (Türkiye)
- Recrutamento
- University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
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Contato:
- Selen Topalel, MD
- Número de telefone: +90 533 506 33 20
- E-mail: selentopalel26@gmail.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:
- Age between 18 and 80 years
- Scheduled for elective isolated coronary artery bypass grafting (CABG) with saphenous vein graft harvesting
- ASA physical status II-IV
- Ability to provide written informed consent
Exclusion Criteria:
- Known coagulopathy or contraindication to regional anesthesia
- Use of anticoagulant therapy precluding regional block
- Known allergy to local anesthetics
- Local infection at planned block sites
- Chronic opioid use or chronic pain syndrome
- Emergency surgery
- Redo sternotomy
- Severe neurological disorder affecting pain assessment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Multimodal Fascial Plane Block Group
Participants will receive a multimodal fascial plane block package consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and before surgical incision, in addition to standard perioperative analgesia.
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Participants will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block after induction of general anesthesia and before surgical incision.
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Comparador Ativo: Standard Analgesia Group
Participants will receive standard perioperative and postoperative analgesia without regional fascial plane block intervention.
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Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.
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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 opioid consumption within the first 48 postoperative hours
Prazo: Through 48 hours after surgery
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Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
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Through 48 hours after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative pain intensity scores
Prazo: At 6, 12, 24, and 48 hours after surgery
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Pain intensity measured using the Numeric Rating Scale (NRS; 0-10) at rest and during movement at predefined postoperative time points.
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At 6, 12, 24, and 48 hours after surgery
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Time to first rescue analgesic requirement
Prazo: Within 48 hours after surgery
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Time from arrival to the intensive care unit to first rescue analgesic administration (hours).
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Within 48 hours after surgery
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Extubation time
Prazo: From ICU admission to extubation, assessed through 24 hours after surgery
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Time from arrival to the intensive care unit to successful tracheal extubation (hours).
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From ICU admission to extubation, assessed through 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Selen Topalel, MD, University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
Publicações e links úteis
Publicações Gerais
- Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
- Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.
- Zhang J, Luo F, Zhang X, Xue Y. Ultrasound-Guided Continuous Parasternal Intercostal Block Relieves Postoperative Pain After Open Cardiac Surgery: A Case Series. J Cardiothorac Vasc Anesth. 2022 Jul;36(7):2051-2054. doi: 10.1053/j.jvca.2021.05.028. Epub 2021 May 21.
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GY-CABG-2026
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Descrição do plano IPD
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