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- Ensaio Clínico NCT07689617
Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery
Effects of Ultrasound-Guided Intermediate Cervical Plexus Block on Postoperative Analgesia and Opioid Consumption in Vagus Nerve Stimulation Surgery: A Prospective Randomized Controlled Trial
Visão geral do estudo
Status
Descrição detalhada
Postoperative pain following vagus nerve stimulation (VNS) implantation surgery originates from both cervical and infraclavicular surgical incisions. Although opioid analgesics are commonly used for postoperative pain control, minimizing opioid exposure is particularly desirable in patients with drug-resistant epilepsy because opioid-related adverse effects may delay recovery and potentially influence neurological assessment.
The intermediate cervical plexus block (ICB) is an ultrasound-guided regional anesthesia technique that provides sensory blockade of the superficial branches of the cervical plexus while allowing accurate deposition of local anesthetic between the investing and prevertebral layers of the deep cervical fascia. Previous studies have demonstrated the effectiveness of cervical plexus blocks in various cervical surgical procedures; however, evidence regarding their use during VNS implantation surgery remains limited.
This prospective, randomized, double-blind, placebo-controlled study compares ultrasound-guided ICB using 10 mL of 0.25% bupivacaine with a placebo injection of 10 mL normal saline administered after induction of general anesthesia. The primary objective is to determine whether ICB reduces postoperative opioid requirements during the first 24 hours after surgery. Secondary objectives include evaluation of intraoperative remifentanil consumption, postoperative pain scores, time to first rescue analgesic, length of hospital stay, and postoperative seizure incidence. The findings are expected to provide evidence regarding the effectiveness and safety of ultrasound-guided intermediate cervical plexus block as part of multimodal analgesia for patients undergoing VNS implantation surgery.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Elâzığ
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Elâzığ, Elâzığ, Turquia (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18-60 years
- American Society of Anesthesiologists (ASA) physical status II-III
- Drug-resistant epilepsy
- Scheduled for elective vagus nerve stimulation implantation surgery under general anesthesia
- Written informed consent obtained
Exclusion Criteria:
- Allergy or contraindication to local anesthetics
- Coagulopathy or current anticoagulant therapy
- Infection at the injection site
- Pregnancy or breastfeeding
- Severe pulmonary disease
- Inability to understand or use the Numeric Rating Scale (NRS)
- Refusal to participate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intermediate Cervical Plexus Block
Participants received an ultrasound-guided intermediate cervical plexus block with 10 mL of 0.25% bupivacaine after induction of general anesthesia before vagus nerve stimulation implantation surgery.
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Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
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Comparador de Placebo: Control
Participants received an ultrasound-guided placebo injection with 10 mL of 0.9% normal saline after induction of general anesthesia before vagus nerve stimulation implantation surgery.
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Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.
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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 postoperative morphine consumption during the first 24 hours after surgery
Prazo: 24 hours after surgery
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Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
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24 hours after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intraoperative remifentanil consumption
Prazo: From induction of anesthesia until the end of surgery
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Total intraoperative remifentanil consumption recorded in micrograms (µg) from induction of anesthesia until completion of surgery.
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From induction of anesthesia until the end of surgery
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Postoperative pain intensity
Prazo: From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
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Pain intensity was assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at PACU admission, 30 minutes after PACU admission, and at postoperative 1, 6, 12, and 24 hours.
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From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
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Time to first rescue analgesic request
Prazo: Within 24 hours after surgery
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Time from arrival in the post-anesthesia care unit (PACU) until the first administration of rescue analgesia, measured in minutes.
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Within 24 hours after surgery
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Length of hospital stay
Prazo: From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
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Time to first rescue analgesic request was defined as the time from PACU arrival to the first request or administration of rescue analgesia.
Patients who did not require rescue analgesia within 24 hours were censored at 24 hours.
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From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
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Postoperative seizure incidence
Prazo: Within 24 hours after surgery
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Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
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Within 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ahmet Aksu, Assistant Professor, Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Dor
- Manifestações Neurológicas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Epilepsia resistente a medicamentos
- Dor, Pós-operatório
- Epilepsia
- Produtos químicos orgânicos
- Terapêutica
- Rotas de administração de medicamentos
- Terapia medicamentosa
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Produtos químicos inorgânicos
- Compostos de cloro
- Compostos de sódio
- Cloretos
- Ácido clorídrico
- Bupivacaína
- Injeções
- Cloreto de sódio
Outros números de identificação do estudo
- 7996
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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