Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.
In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.
The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.
Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.
One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.
Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.
To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.
The clinical impact of a femoral nerve block with an analgesic duration of 20 hours compared to the present 15 hours would be less patients waking up in wards during the night time with pain and a terminated femoral nerve block.
The purpose of this study is to investigate if more patients with hip fracture experience a lasting preoperative analgesic duration of at least 20 hours or until the time of operation after a femoral nerve block with Bupivacaine with adrenaline and the addition of Dexamethasone compared to the same nerve block done with only Bupivacaine with adrenaline.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Aarhus, Dinamarca, 8000
- Aarhus University Hospital
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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 pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Verbal pain score > 3, 30 minutes after the nerve block
- Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
- Patient has previously been included in this trial
- Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
- Verbal pain score > 3 from other locations than the fractured hip
- 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
- Acute inability to comprehend and use verbal pain score
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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Comparador de placebos: Saline
Bupivacaine with adrenaline with 2 ml. of Saline added
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Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
Otros nombres:
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Experimental: Dexamethasone
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
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Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Frequency of analgesia at the time of operation or at 20 hours
Periodo de tiempo: Until the start of the operation or at 20 hours, average 18 hours
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Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
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Until the start of the operation or at 20 hours, average 18 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Frequency of analgesia at the time of operation or at 22 hours
Periodo de tiempo: Until the start of the operation or at 22 hours, average 20 hours
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Frequency of analgesia at the time of operation or at 22 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
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Until the start of the operation or at 22 hours, average 20 hours
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Frequency of analgesia at the time of operation or at 24 hours
Periodo de tiempo: Until the start of the operation or at 24 hours, average 22 hours
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Frequency of analgesia at the time of operation or at 24 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
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Until the start of the operation or at 24 hours, average 22 hours
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Frequency of satisfactory analgesia
Periodo de tiempo: Until the start of the operation or at 20 hours, average 18 hours
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Frequency of patients with satisfactory analgesia i the period from the nerve block until the time of operation or at 20 hours compared between the groups
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Until the start of the operation or at 20 hours, average 18 hours
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Time to wish for opioid analgesia
Periodo de tiempo: Until the start of the operation or at 24 hours, average 22 hours
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Mean time fra nerve block to wish for opioid analgesia compared between groups
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Until the start of the operation or at 24 hours, average 22 hours
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Use of opioid analgesia until 20 hours
Periodo de tiempo: Until the start of the operation or at 20 hours, average 18 hours
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Mean use of opioid analgesia until the time of operation or at 20 hours compared between groups
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Until the start of the operation or at 20 hours, average 18 hours
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Use of opioid analgesia until 22 hours
Periodo de tiempo: Until the start of the operation or at 22 hours, average 20 hours
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Mean use of opioid analgesia until the time of operation or at 22 hours compared between groups
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Until the start of the operation or at 22 hours, average 20 hours
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Use of opioid analgesia until 24 hours
Periodo de tiempo: Until the start of the operation or at 24 hours, average 22 hours
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Mean use of opioid analgesia until the time of operation or at 24 hours compared between groups
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Until the start of the operation or at 24 hours, average 22 hours
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Time to analgesic effect with patient at rest
Periodo de tiempo: 30 minutes
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Mean time from nerve block to verbal pain score ≤3 at rest
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30 minutes
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Time to analgesic effect measured while doing passive leg raise
Periodo de tiempo: 30 minutes
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Mean time from nerve block to verbal pain score ≤5 while doing passive leg raise
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30 minutes
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Frequency of insufficient analgesia
Periodo de tiempo: 30 minutes
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Frequency of patients with hip fracture with insufficient analgesia after femoral nerve block at 30 minutes
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30 minutes
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Frequency of absent analgesia
Periodo de tiempo: 30 minutes
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Frequency of patients with hip fracture with absent analgesia after femoral nerve block at 30 minutes
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30 minutes
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Frequency of patients without sufficient analgesia
Periodo de tiempo: 30 minutes
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Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes
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30 minutes
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Skin sensation in saphenous area
Periodo de tiempo: 30 minutes
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Frequency of reduced cold sensation in the skin area innervated by the saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
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30 minutes
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Skin sensation in area of the anterior cutaneous branches of the femoral nerve
Periodo de tiempo: 30 minutes
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Frequency of reduced cold sensation in the skin area innervated by the anterior cutaneous branches of the femoral nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block
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30 minutes
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Sufficient analgesia Dexamethasone vs. plain
Periodo de tiempo: 30 minutes
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Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain bupivacaine
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30 minutes
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Nerve visualization
Periodo de tiempo: Just before injection, which is within an expected average of 10 minutes after inclusion
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Frequency of possible ultrasound visualization of the femoral nerve
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Just before injection, which is within an expected average of 10 minutes after inclusion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Thomas F. Bendtsen, MD, Ph.d., Aarhus University Hospital
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
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
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Dexametasona
Otros números de identificación del estudio
- protocol1tdn
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Ensayos clínicos sobre Saline
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