- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02760043
Dexamethasone in Total Knee and Total Hip Arthroplasty
Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules.
With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Vincent Chan, MD
- Número de teléfono: 4166035118
- Correo electrónico: vincent.chan@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: Kariem El-Boghdadly, MD
- Número de teléfono: 4166035800
- Correo electrónico: elboghdadly@gmail.com
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5T2S8
- Reclutamiento
- Toronto Western Hopspital
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Investigador principal:
- Vincent Chan, MD. FRCPC
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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:
- Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia
- ASA-PS I-III
- 18-85 years of age, inclusive
- 50-100 kg, inclusive
- BMI 18 - 40
Exclusion Criteria:
- Revision hip/knee arthroplasty
- Bilateral hip/knee arthroplasty
- Inability or refusal to provide informed consent
- Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)
- Allergy to local anesthesia, ketorolac or dexamethasone
- Allergy to opioids
- Chronic pain state, neuropathic pain
- Opioid dependence
- Diabetic patients will NOT be excluded except those with significant peripheral neuropathy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
|
8mg (2mL) of Dexamethasone added to standard LIA mixture
Otros nombres:
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
|
Comparador falso: Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
|
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Periodo de tiempo: 3 days - post operative
|
3 days - post operative
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Analgesic outcomes- pain
Periodo de tiempo: 3 days - post operative
|
Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points:
g. POD 3 during physiotherapy if still in hospital |
3 days - post operative
|
Analgesic outcomes- opiate consumption
Periodo de tiempo: 3 days - post operative
|
Cumulative systemic opioid consumption measured as oral morphine mg equivalents on POD 1, POD2, and, if still in hospital, POD 3, as well as the proportion of patients who required "rescue" intravenous patient controlled analgesia (IV PCA) anytime in the postoperative period
|
3 days - post operative
|
Analgesic outcomes- TUG test
Periodo de tiempo: 3 days - post operative
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Timed Up and Go Test (TUG) on postoperative days 2 or 3
|
3 days - post operative
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Analgesic outcomes- Drug side-effects
Periodo de tiempo: 3 days - post operative
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Incidence of opioid-related side effects:
|
3 days - post operative
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Short-term physical and performance-based functional outcome measures- in hospital complications
Periodo de tiempo: 3 days post operative
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In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay
|
3 days post operative
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Short-term physical and performance-based functional outcome measures- length of stay
Periodo de tiempo: 3 days - post operative
|
Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery
|
3 days - post operative
|
Short-term physical and performance-based functional outcome measures- discharge
Periodo de tiempo: 3 days - post operatively
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Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre
|
3 days - post operatively
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Medium-term self-reported functional outcome measures- WOMAC
Periodo de tiempo: 3 months- post operative
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
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3 months- post operative
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Medium-term self-reported functional outcome measures- LFES
Periodo de tiempo: 3 months- post operative
|
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
|
3 months- post operative
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- El-Boghdadly K, Short AJ, Gandhi R, Chan V. Addition of dexamethasone to local infiltration analgesia in elective total knee arthroplasty: double-blind, randomized control trial. Reg Anesth Pain Med. 2021 Feb;46(2):130-136. doi: 10.1136/rapm-2020-102079. Epub 2020 Nov 16.
- El-Boghdadly K, Short AJ, Gandhi R, Chan VWS. Addition of dexamethasone to local infiltration analgesia in elective total hip arthroplasty: a double-blind, randomized control trial. Reg Anesth Pain Med. 2019 Sep 27:rapm-2019-100873. doi: 10.1136/rapm-2019-100873. Online ahead of print.
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 (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
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Artritis
- Osteoartritis
- 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
- UHN15-9898-A
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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