- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00967980
Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.
Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92103
- UCSD Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- primary, unilateral hip arthroplasty or hip resurfacing
- age greater than or equal to 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion
Exclusion Criteria:
- morbid obesity (BMI greater than 40)
- chronic, high-dose opioid use
- history of opioid abuse
- pregnancy
- incarceration
- amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
- inability to communicate with hospital staff
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 |
---|---|
Comparador activo: 1. Femoral Nerve Block
Patients will be randomized with a computer program to receive a femoral catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
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Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
|
Comparador activo: 2. Psoas Compartment Catheter
Patients will be randomized with a computer program to receive a psoas compartment catheter.
The catheter will be placed using standard technique.
The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort.
|
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block.
Patients randomized to femoral nerve block will receive this block prior to surgery.
Patients randomized to psoas compartment nerve block will receive this block prior to surgery.
Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.
Periodo de tiempo: 24 hours beginning 7:30am day following surgery
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24 hours beginning 7:30am day following surgery
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Analgesic used, as reported by nursing staff in the UCSD computer system.
Periodo de tiempo: 3 days following surgery
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3 days following surgery
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Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.
Periodo de tiempo: 3 days following surgery
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3 days following surgery
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Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.
Periodo de tiempo: 3 days following surgery
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3 days following surgery
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Infusion duration of pain pump, measured on the pump itself in hours and minutes.
Periodo de tiempo: 3 days following surgery
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3 days following surgery
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Duration of hospital stay, in hours, as reported in the UCSD computer system.
Periodo de tiempo: 3 days following surgery
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3 days following surgery
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Surgical/anesthetic adverse events as reported by hospital staff
Periodo de tiempo: day of surgery and 3 days following
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day of surgery and 3 days following
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Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.
Periodo de tiempo: 1 week following surgery
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1 week following surgery
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Femoral vs. Psoas PNB Cath Hip
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