Nociception Level Index Monitoring During Cesarean Section (NOL-CS)
Effect of Nociception Level Index-Guided Intraoperative Analgesia on Postoperative Pain Management During Elective Cesarean Section
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Postoperative pain following cesarean section remains an important clinical concern because inadequate analgesia may delay maternal recovery, increase opioid consumption, and negatively affect early breastfeeding and maternal-infant bonding. Conventional intraoperative monitoring does not directly assess nociceptive responses, making individualized analgesic administration challenging.
The Nociception Level (NOL) index is a multiparametric monitoring system that integrates photoplethysmography, galvanic skin response, peripheral temperature, and accelerometer signals to provide an objective assessment of nociception during anesthesia. This technology may enable more individualized opioid administration based on the patient's nociceptive response.
In this prospective randomized controlled trial, patients undergoing elective cesarean section under general anesthesia were randomized to receive either NOL-guided intraoperative analgesia or standard intraoperative monitoring. In the intervention group, fentanyl administration after fetal delivery was guided by the NOL index, whereas patients in the control group received conventional hemodynamic-guided analgesia.
Postoperative pain was evaluated using the visual analog scale (VAS) at predefined time points during the first 24 postoperative hours. Rescue opioid requirements, total postoperative analgesic consumption, and time to first breastfeeding were also recorded. The study was designed to determine whether NOL-guided analgesia could improve early postoperative pain control and reduce postoperative opioid requirements compared with conventional monitoring.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sultangazi
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Istanbul, Sultangazi, Turquía (Türkiye), 34256
- University of Health Sciences Türkiye Haseki Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female patients undergoing elective cesarean section under general anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:
- Refusal to participate.
- Emergency cesarean section.
- High-risk pregnancy (including hypertensive disorders of pregnancy, diabetes mellitus, preterm labor, or fetal growth restriction).
- Placental abnormalities.
- History of allergy to any study medication.
- History of malignant hyperthermia.
- Alcohol or substance abuse.
- Severe cardiac disease or severe arrhythmia.
- Peripheral vascular disease.
- Renal or hepatic failure.
- Contraindication to corticosteroid administration.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: NOL-Guided Analgesia Group
Patients undergoing elective cesarean section under general anesthesia were monitored intraoperatively using the Nociception Level (NOL) index in addition to standard monitoring.
After fetal delivery, fentanyl was administered in 25-mcg boluses when the NOL value remained above 25 for more than 1 minute, with a minimum interval of 5 minutes between doses.
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The Nociception Level (NOL) index was used to guide intraoperative fentanyl administration after fetal delivery.
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Comparador activo: Standard Monitoring Group
Patients undergoing elective cesarean section under general anesthesia received standard intraoperative monitoring.
Intraoperative analgesic management was performed according to conventional clinical practice without NOL index guidance.
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Standard intraoperative monitoring was used for routine anesthetic and analgesic management without NOL index 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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Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
Periodo de tiempo: 10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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Postoperative pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 indicated the worst imaginable pain.
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10 minutes, 30 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to first breastfeeding
Periodo de tiempo: Within the first postoperative hour
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The time elapsed from the end of surgery until the first successful breastfeeding was recorded in minutes.
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Within the first postoperative hour
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Need for rescue analgesia
Periodo de tiempo: Within the first 24 hours after surgery
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The proportion of patients requiring additional postoperative analgesia was recorded.
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Within the first 24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
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 del Sistema Nervioso
- Complicaciones Postoperatorias
- Procesos Patológicos
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Comportamiento de alimentación
- Dolor Postoperatorio
- Agnosia
- Lactancia Materna
Otros números de identificación del estudio
- HASEKI-36-408-2023
Plan de datos de participantes individuales (IPD)
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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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