Bloqueo del nervio del plexo braquial versus atención estándar para la reducción cerrada de la fractura del radio distal en adultos: el ensayo BLOCK. un ensayo controlado aleatorio multicéntrico nacional
The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark.
Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:
- A nerve block of the arm (plexus brachialis block)
- A haematoma block, which is the current standard anaesthesia in the emergency departments.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Capital Region
-
Hillerød, Capital Region, Dinamarca, 3400
- Copenhagen University Hospital - North Zealand Hillerød
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion Criteria:
- Patients who would never qualify for surgery according to local guidelines
- Lack of informed consent
- No Danish Central Person Register (CPR) number
- Allergies to the trial medication
- Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
- Open fractures (fracture-related wound requiring sutures)
- Other fractures on the same extremity ((NOT including distal ulna fracture(s))
- Bilateral distal radius fractures both requiring closed reduction
- Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention group
Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections. |
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block |
|
Comparador activo: Control group
Haematoma block with local anaesthetics i.e. lidocaine with adrenaline |
Participants will receive no peripheral nerve block and receive a haematoma block, with or without supplemental sedation and/or systemic analgesia for the closed reduction according to local guidelines and clinical practices |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proporción acumulada de pacientes con cirugía de fractura de radio distal
Periodo de tiempo: 90 días después de la reducción cerrada
|
90 días después de la reducción cerrada
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Composite outcome of treatment related complications
Periodo de tiempo: 90 days after closed reduction
|
loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries (including skin injuries) related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment (including compression), pneumothorax, allergic reaction, new bone or joint injury (e.g. dislocation or fracture) after the closed reduction and/or pulmonary embolism |
90 days after closed reduction
|
|
Patient Rated Wrist Evaluation (PRWE)
Periodo de tiempo: 90 days after closed reduction
|
The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
90 days after closed reduction
|
|
Maximum pain score in the affected wrist during closed reduction(s)
Periodo de tiempo: 0-12 hours after the closed reduction
|
The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. If the patient has the closed reduction performed more than one time, the patient will be asked to report the worst pain experienced during all the attempts of a closed reduction. |
0-12 hours after the closed reduction
|
|
Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction
Periodo de tiempo: 0 -24 hours after closed reduction
|
The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
0 -24 hours after closed reduction
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Número de intentos utilizados para la reducción cerrada
Periodo de tiempo: Inmediatamente después de la reducción cerrada
|
Inmediatamente después de la reducción cerrada
|
|
|
Proporción de complicaciones individuales en el resultado secundario compuesto
Periodo de tiempo: 90 días después de la reducción cerrada
|
90 días después de la reducción cerrada
|
|
|
Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction
Periodo de tiempo: 0-12 hours, 90 days and 12 months after closed reduction
|
The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. |
0-12 hours, 90 days and 12 months after closed reduction
|
|
Maximum pain in the affected wrist within the first 24 hours after closed reduction
Periodo de tiempo: 24-36 hours after the closed reduction.
|
The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable. |
24-36 hours after the closed reduction.
|
|
Proportion of patients with complex regional pain syndrome (CRPS)
Periodo de tiempo: 90 days and 12 months after closed reduction
|
CRPS is defined according to the Budapest Criteria |
90 days and 12 months after closed reduction
|
|
Disabilities of the Arm, Shoulder, and Hand (DASH) score
Periodo de tiempo: 90 days and 12 months after closed reduction
|
DASH-score is calculated from the Danish-validated translation of the DASH questionnaire |
90 days and 12 months after closed reduction
|
|
Patient Rated Wrist Evaluation (PRWE)
Periodo de tiempo: 12 months after closed reduction
|
PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
12 months after closed reduction
|
|
Quality of life (EQ-5D-5L) score
Periodo de tiempo: 90 days and 12 months after closed reduction
|
The Danish translation of the EQ-5D-5L questionnaire is used and the EQ-5D-5L-score is calculated based on the Danish EQ-5D-5L value set |
90 days and 12 months after closed reduction
|
|
Difficulty of closed reduction of the fracture
Periodo de tiempo: Immediately after closed reduction
|
The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult) |
Immediately after closed reduction
|
|
Discomfort related to the anaesthetic procedure
Periodo de tiempo: 0-12 hours after closed reduction
|
The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable |
0-12 hours after closed reduction
|
|
Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia
Periodo de tiempo: 24 hours after closed reduction
|
The overall satisfaction is a patient-reported outcome on a numeric rating scale from 0-10; 0=very unsatisfied, 10=very satisfied. When evaluating the treatment, the patient is specifically asked to include all elements of the treatment including: the anaesthetic (procedure and following effects), the experience during the closed reduction and the pain and general sensation in the arm/wrist in the first 24 hours after the treatment commencement. |
24 hours after closed reduction
|
|
Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction)
Periodo de tiempo: 10-14 days after closed reduction
|
The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
10-14 days after closed reduction
|
|
Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function
Periodo de tiempo: Within 90 days after closed reduction
|
A SAE is defined as an adverse event that leads to the following incidents:
Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE. |
Within 90 days after closed reduction
|
|
Proportion of patients having one or more adverse events (AEs)
Periodo de tiempo: Within 24 hours after closed reduction
|
An AE is defined as any harmful and unintended event, sign, or symptom, that appear during the trial period, regardless of whether this AE is considered related to the treatment or not. |
Within 24 hours after closed reduction
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cecilie D Harwood, MD, PhD-fellow, Copenhagen University Hospital - North Zealand
- Investigador principal: Anne-Sofie Jellestad, MD, PhD-fellow, Copenhagen University Hospital - North Zealand
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CTA no: 2024-512191-35-00
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .