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Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery

20. juni 2014 oppdatert av: Royal Marsden NHS Foundation Trust

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

154

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • London, Storbritannia, SW3 6JJ
        • The Royal Marsden Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.

Andre navn:
  • Pregabalin
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
Ingen inngripen: Usual care
These partcipants will receive usual care before, during and after their breast surgery

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
Tidsramme: 3 months
3 months

Sekundære resultatmål

Resultatmål
Tidsramme
The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
Tidsramme: 3 and 12 months
3 and 12 months
The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
Tidsramme: 3 and 12 months
3 and 12 months
The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
Tidsramme: 3 and 12 months
3 and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: JOHN E WILLIAMS, MB BS FRCA, The Royal Marsden Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2014

Primær fullføring (Forventet)

1. februar 2017

Studiet fullført (Forventet)

1. februar 2018

Datoer for studieregistrering

Først innsendt

19. juni 2014

Først innsendt som oppfylte QC-kriteriene

20. juni 2014

Først lagt ut (Anslag)

23. juni 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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