- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, SW3 6JJ
- The Royal Marsden Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
Altri nomi:
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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Nessun intervento: Usual care
These partcipants will receive usual care before, during and after their breast surgery
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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.
Lasso di tempo: 3 months
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3 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 3 and 12 months
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3 and 12 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: JOHN E WILLIAMS, MB BS FRCA, The Royal Marsden Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema nervoso
- Complicanze postoperatorie
- Dolore
- Manifestazioni neurologiche
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Dolore, Postoperatorio
- Nevralgia
- Dolore Cancro
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Agenti tranquillanti
- Psicofarmaci
- Modulatori di trasporto a membrana
- Agenti anti-ansia
- Anticonvulsivanti
- Ormoni e agenti regolatori del calcio
- Bloccanti dei canali del calcio
- Anestetici
- Pregabalin
- Anestetici, Locali
Altri numeri di identificazione dello studio
- CCR 4116
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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