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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Elâzığ
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Elâzığ, Elâzığ, Turquía (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total postoperative morphine consumption during the first 24 hours after surgery
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative remifentanil consumption
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Dolor
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Epilepsia resistente a los medicamentos
- Dolor Postoperatorio
- Epilepsia
- Químicos orgánicos
- Terapéutica
- Rutas de administración de drogas
- Terapia con drogas
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Químicos inorgánicos
- Compuestos de cloro
- Compuestos de sodio
- Cloruros
- Ácido clorhídrico
- Bupivacaína
- Inyecciones
- Cloruro de sodio
Otros números de identificación del estudio
- 7996
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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