- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01911949
USFIB at the Inguinal Ligament for Total Hip Arthroplasty
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ultrasound guided femoral blocks have been studied since the late 90's. A study published in 1997 by Marhofer et al. pointed that ultrasound guidance in a 3-in-1 block (femoral, obturator, lateral cutaneous nerves), improved the quality of the sensory block and reduced the onset time when compared with a nerve-stimulation technique in patients undergoing hip surgery after trauma.(13) In a meta-analysis comparing ultrasound guidance versus electrical nerve-stimulation for peripheral nerve blocks, the authors reported a decreased risk of block failure, shorter procedure time and faster onset time when ultrasound is used.(14)
A systematic review studying the outcomes after Total Hip Arthroplasty concluded that when compared with systemic analgesia the use of femoral nerve block was on unclear benefit.(15) Separate analysis of the two studies included showed that in the Biboulet study, ultrasound was not used to perform the blocks, and pain with activity was not evaluated in the first 24 hours after surgery, time in which the maximum benefit of blocks is observed.(16) In the second study by Singelyn et al. with continuous femoral nerve block, the authors found similar pain relief than with IV Patient Controlled Analgesia morphine with fewer side effects.(17)
While recent publications have demonstrated the analgesia effectiveness of femoral nerve block and fascia iliaca block for hip fractures,(18) there are not references in the literature analyzing the effectiveness of a single shot, ultrasound-guided, femoral nerve block in primary hip arthroplasty. This fact opens up the possibility to continue researching the analgesic effectiveness of this block in a population where the options for handling postoperative pain are limited widely for its side effects together with the use of anticoagulant and anti-thrombotic therapy.
This technique is considered a simple procedure, easy to teach and to learn. If our study shows improvement of the outcomes, it will feasible to incorporate this block as an alternative for pain management after primary hip arthroplasty.
Given the complexity of this proposed randomized-controlled trial, a pilot study was deemed necessary to find out the feasibility and safety of the intervention, rate of patient recruitment and needs for additional personnel.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Ontario
-
Hamilton, Ontario, Canadá, L8N 4A6
- St. Joseph's Heathcare Hamilton
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients 18 years or older undergoing unilateral hip arthroplasty.
- Patient capable to complete informed consent.
Exclusion Criteria:
- Pediatric population.
- Inability to complete informed consent.
- Patient refusal.
- Contraindication for regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection, local anesthesia allergy.
- Presence of neuromuscular deficit including diabetic peripheral neuropathy.
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 |
|---|---|
|
Experimental: Single shot femoral nerve block
Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine
|
Nerve block in lingual crease using ultrasound guidance
Otros nombres:
|
|
Comparador de placebos: Placebo femoral nerve block
Sterile normal saline solution
|
Nerve block in lingual crease using ultrasound guidance
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Periodo de tiempo: Three months
|
Three months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of eligible patients consenting to participate.
Periodo de tiempo: Three months
|
Three months
|
|
Number of patients participating that were randomized and received the study intervention.
Periodo de tiempo: Three months
|
Three months
|
|
Completion of study data collection forms
Periodo de tiempo: Three months
|
Three months
|
|
Incidence of respiratory depression and seizures in participating subjects
Periodo de tiempo: Three months
|
Three months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mauricio Forero, MD, St. Joseph's Healthcare Hamilton
Publicaciones y enlaces útiles
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 (Estimado)
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
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Catecols
- Fenoles
- Derivados de benceno
- Alcoholes
- Amino alcoholes
- Etanolaminas
- Monoaminas biogénicas
- Aminas biogénicas
- Catecolaminas
- Bupivacaína
- Epinefrina
Otros números de identificación del estudio
- 12-3688
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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