Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively. (PENGBlock)
Evaluation of the PENG Block vs Placebo for Preoperative Pain Control in Hip Fractures in the Elderly - a Double-blinded Randomised Controlled Trial
Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.
The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.
Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 169608
- Reclutamiento
- Pain Management Center Sinagpore General Hospital
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Contacto:
- Diana Xin Hui Chan
- Número de teléfono: 63266162
- Correo electrónico: diana.chan.x.h@singhealth.com.sg
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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:
- Age 60 years old and above
- Provided consent for the study
- Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
- Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours
Exclusion Criteria:
- Patients with cognitive impairment or inability to give consent, or refusal to give consent
- Multiple fracture cases
- Peri-prosthetic fractures and revisions
- Subclinical vertebral fractures
- Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
- Multiple trauma
- Pathological fractures secondary to metastases
Patients with contraindications to block performance
- Coagulopathy as demonstrated by PT/PTT/INR
- On antiplatelets or anticoagulation
- Infection/ compromised skin integrity at site of block performance
- Allergy to local anaesthetics and opioids
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 |
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Comparador de placebos: Control
Only standard care
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Atención estándar
Otros nombres:
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Experimental: Intervention group
The PENG block was performed for intervention group with local anaesthetic solution composed of 20 ml of ropivacaine 0.5%.
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Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Dynamic pain scores (Numerical pain score (NRS) at 15 degrees leg lift)
Periodo de tiempo: 30 minutes after receiving intervention
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The difference in dynamic pain scores (NRS at 15 degrees leg lift) at 30 minutes post block performance in the intervention group vs the control group.
Assessment of the dynamic pain score is done prior to discharge from recovery at SGH Pain Management Centre.
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30 minutes after receiving intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain scores (NRS) at rest (static pain) and on movement (dynamic pain)
Periodo de tiempo: Up to 24 hours from performance of block
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It is measured at Baseline, Immediately after performance of block, 30 minutes after the lock in recovery At 60 minutes, 180 minutes and 24 hours post block in the ward
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Up to 24 hours from performance of block
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Pain scores collected to estimate the onset and duration of block Pain scores to estimate the onset and duration of block
Periodo de tiempo: Up to 24 hours from performance of block
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Taking the recorded time taken for the pain relieve to estimate onset time using models
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Up to 24 hours from performance of block
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Total opioid use over 24 hours as a surrogate measure
Periodo de tiempo: Up to 24 hours from performance of block
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Using the data recorded for : Oral morphine use Intravenous morphine use for patients on PCA Doses of opioid use will be converted to morphine milligram equivalent daily dose (MEDD) for standardized comparison. |
Up to 24 hours from performance of block
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Tay E. Hip fractures in the elderly: operative versus nonoperative management. Singapore Med J. 2016 Apr;57(4):178-81. doi: 10.11622/smedj.2016071.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- 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
- Ropivacaína
Otros números de identificación del estudio
- 2 (Otro identificador: Instituto Cardiovascular de Buenos Aires)
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.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Fracturas de cadera
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Aarhus University HospitalUniversity of AarhusReclutamientoCoxa saltans externo | HiP externoDinamarca