Obturator and Femoral Nerve Block in Patients With Hip Fracture
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Aarhus, Dinamarca, 8000
- Reclutamiento
- Aarhus University Hospital
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Contacto:
- Thomas D. Nielsen, MD
- Número de teléfono: +45 28782877
- Correo electrónico: thomas.dahl.nielsen@clin.au.dk
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Contacto:
- Thomas F. Bendtsen, MD, Ph.d.
- Número de teléfono: +45 51542997
- Correo electrónico: tfb@dadlnet.dk
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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:
- Clinical suspicion of hip fracture
- Age ≥ 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Bupivacaine
Obturator nerve block
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Obturator nerve block
Otros nombres:
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Comparador de placebos: Saline
Saline is injected as a placebo
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Obturator nerve block with saline(placebo)
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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Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Periodo de tiempo: 30 minutes
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Success rate of successful analgesia compared between the groups
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30 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Median pain score (NRS 0-10)
Periodo de tiempo: 30 minutes
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Median pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Median change in pain score (NRS 0-10)
Periodo de tiempo: 30 minutes
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Median change in pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
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Course in pain reduction
Periodo de tiempo: 30 minutes
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Course in pain reduction during the 30 minutes after the nerve blocks
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30 minutes
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Time to sufficient analgesia
Periodo de tiempo: 30 minutes
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Time from ended injection until sufficient analgesia
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30 minutes
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Frequency of anesthesia in the skin area of the saphenous nerve
Periodo de tiempo: 30 minutes
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Frequency of anesthesia in the skin area innervated by the saphenous nerve
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30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Periodo de tiempo: 30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
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30 minutes
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Localization of the worst pain before block
Periodo de tiempo: 0 minutes
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Localization of the worst pain before any nerve blocks
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0 minutes
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Localization of the worst pain after block
Periodo de tiempo: 30 minutes
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Localization of the worst pain 30 minutes after the nerve blocks
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30 minutes
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Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Periodo de tiempo: 5 minutes
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Discomfort during the nerve block procedures compared between procedures
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5 minutes
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Satisfaction (0-10, 0= very unsatisfactory)
Periodo de tiempo: 30 minutes
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Patient satisfaction with the pain treatment
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30 minutes
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Frequency of ultrasound visualization of femoral nerve
Periodo de tiempo: 5 minutes
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Frequency of patients with possible ultrasound visualization af the femoral nerve
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5 minutes
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Frequency of ultrasound visualization of obturator injection site
Periodo de tiempo: 5 minutes
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Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
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5 minutes
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Time spend on femoral nerve block
Periodo de tiempo: 5 minutes
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Time spend on conducting the femoral nerve block
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5 minutes
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Time spend on obturator nerve block
Periodo de tiempo: 5 minutes
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Time spend on conducting the obturator nerve block
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5 minutes
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Total morphine equivalent dose of opioid from the time of nerve block to operation
Periodo de tiempo: Approximately 24 hours in average
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Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Periodo de tiempo: Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Periodo de tiempo: 10 hours
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Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
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10 hours
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Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Periodo de tiempo: 10 hours
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Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
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10 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Lesiones en las piernas
- Fracturas Femorales
- Lesiones de cadera
- Fracturas, Hueso
- Fracturas de cadera
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Anestésicos
- Anestésicos Locales
- Bupivacaína
Otros números de identificación del estudio
- protocol2_2tdn
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