Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)
1 de febrero de 2014 actualizado por: Fu Zhou Wang, Nanjing Medical University
Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control.
Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics.
However, we unavoidably encounter many opioid-associated side effects during the labor delivery.
In addition, usage of opioid increase the medical cost for each patient.
We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
500
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210004
- Nanjing Maternity and Child Health Care Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Nulliparas
- Request epidural analgesia
- Chinese
Exclusion Criteria:
- Allergic to opioid or local anesthetics
- Fail to perform epidural puncture and catheterization
- Organ dysfunction
- Contraindications for epidural anesthesia
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
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0.125% ropivacaine 10-15 ml every 1h during labor delivery
Otros nombres:
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Comparador activo: Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
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Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain scorings
Periodo de tiempo: up to 3 days
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Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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up to 3 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pruritus
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Dizziness
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Nausea
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Vomiting
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Drowsiness
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Sedation
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Respiratory depression
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Psychological effects
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Myoclonus
Periodo de tiempo: From post-randomization to post-delivery day 3
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This describes muscle rigidity and abnormal movement of the limbs and muscles. Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3. |
From post-randomization to post-delivery day 3
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Maternal heart rate
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Miosis
Periodo de tiempo: From post-randomization to post-delivery day 3
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Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
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From post-randomization to post-delivery day 3
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Cesarean section
Periodo de tiempo: The time at the end of the labor delivery
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Record the incidence of Cesarean section after completion of the labor delivery.
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The time at the end of the labor delivery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to latent phase
Periodo de tiempo: From the beginning of regular contraction of uterus to the dilation of cervical 4cm
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Record the time duration
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From the beginning of regular contraction of uterus to the dilation of cervical 4cm
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Time of active phase
Periodo de tiempo: From the cervix 4cm to the dilation of cervical 10cm
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Record the time duration
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From the cervix 4cm to the dilation of cervical 10cm
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Overall satisfaction of analgesia
Periodo de tiempo: At the time of the end of the labor delivery
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Assess the analgesia satisfaction after the completion of the labor delivery
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At the time of the end of the labor delivery
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Oxytocin usage
Periodo de tiempo: At the time of the end of the labor
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Record the total usage of oxytocin after completion of the labor delivery
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At the time of the end of the labor
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Neonatal Apgar score
Periodo de tiempo: At the time of the baby was born, 1min, 5min, 10min and 20min
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At the time of the baby was born, 1min, 5min, 10min and 20min
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Instrumental delivery
Periodo de tiempo: At the time of the end of the labor
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Record the incidence of instrumental delivery after completion of the labor delivery.
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At the time of the end of the labor
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Umbilical gas analysis
Periodo de tiempo: At the time of the fetus was delivery
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At the time of the fetus was delivery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2013
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
11 de enero de 2014
Primero enviado que cumplió con los criterios de control de calidad
13 de enero de 2014
Publicado por primera vez (Estimar)
14 de enero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
1 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Analgésicos Opiáceos
- Estupefacientes
- Adyuvantes, Anestesia
- Anestésicos
- Anestésicos Locales
- Ropivacaína
- Sufentanilo
Otros números de identificación del estudio
- NJFY13007
- JQX12009 (Otro número de subvención/financiamiento: Nanjing Municipal Bureau of Health)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .