- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02170415
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Numerous surveys have shown that following breast surgery, longterm pain affects around half of patients. Given that 1 in 9 women will get breast cancer and that surgery is the cornerstone of treatment, persistent pain represents a major challenge. In addition to the suffering chronic pain causes to individual patients, the investigators know that it places a substantial burden on families and carers, and that patients with pain represent an excessive demand on healthcare resources.
This research will evaluate the impact of introducing a proactive, integrated care plan for patients having breast surgery. It will assess the effect of the care plan on reducing the number of patients with pain at 3 and 12 months after their procedure.
The personalised plan involves numerous evidence based steps linked by a single unifying description aimed at controlling pain, before, during and after the procedure, in hospital and at home.
Patients at risk of developing pain will be identified prior to the procedure and randomly allocated to follow either the personalised care plan or to receive 'usual' care. In the personalised care plan group, participants will get information about chronic pain, be screened for pain and offered immediate treatment. During their procedure both the surgeon and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the likelihood of experiencing pain.
After their procedure, patients will be again screened for pain and further treatment instigated. Physiotherapists and other allied health professionals such as psychologists will also be involved as appropriate. A package of care for pain will then be passed on to the patients' GP, in the form of a written pain management plan, for ongoing care which will be linked to the hospital. Patients from both groups will be followed up for a year at regular intervals.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW3 6JJ
- The Royal Marsden 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:
- Women aged 18 and over with breast cancer undergoing breast surgery at the Royal Marsden Hospital. This includes mastectomy, wide local excision with axillary clearance, breast reconstruction surgery i.e Diep flap, LD flap
Exclusion Criteria:
- Previous thoracic surgery.
- Symptomatic angina pectoris.
- Renal impairment.
- Inability to read or to understand consent documentation.
- Patients undergoing the following surgery; lumpectomy, wide local excision, cosmetic procedures, any day-case breast surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Intervention limb
Medical review and analgesic optimisation. Pain education (in the form of leaflet and website recommendations) Psychological input for patients with evidence of psychological morbidity. Protective analgesia - one pre-procedure dose of 150mg oral pregabalin. Five days post-procedure oral pregablin twice daily at a dose of 75mg twice a day. Patients offered a paravertebral block, local anaesthetic infiltrated around the wound by the surgeon. Daily, focused visits from the hospital pain team. Any patient displaying concerning pain symptoms, behaviour or who underwent prolonged (>3 hours surgery) may be booked for early 'preemptive' review in pain clinic. |
Participants in the intervention arm of the study (if no contraindications exist) will be administered one pre-procedure dose of 150mg of oral pregabalin. For a total of five days post-procedure the participants in the intervention limb of the study will take oral pregablin twice daily at a dose of 75mg twice a day.
Otros nombres:
Participant will receive a pain education leaflet
Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
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Sin intervención: Usual care
These partcipants will receive usual care before, during and after their breast surgery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
Periodo de tiempo: 3 months
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
Periodo de tiempo: 3 and 12 months
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3 and 12 months
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The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
Periodo de tiempo: 3 and 12 months
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3 and 12 months
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The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
Periodo de tiempo: 3 and 12 months
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3 and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: JOHN E WILLIAMS, MB BS FRCA, The Royal Marsden Hospital
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 (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
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Dolor Postoperatorio
- Neuralgia
- Dolor por cáncer
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes tranquilizantes
- Drogas psicotropicas
- Moduladores de transporte de membrana
- Agentes contra la ansiedad
- Anticonvulsivos
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Anestésicos
- Pregabalina
- Anestésicos Locales
Otros números de identificación del estudio
- CCR 4116
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