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

Unknown statusNot applicableNCT02170415
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Conditions
Interventions
  • Drug: Protective analgesia
  • Other: Pain education
  • Behavioral: Psychological support
  • Procedure: Paravertebral block/local anaesthetic infiltration
  • Other: Daily visits from pain team whilst in hospital
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom; Institute of Cancer Research, United Kingdom
Start date
2014-06
Primary completion
2017-02
Sex
Female
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02170415