NCT02170415

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Persistent Post-surgical Pain
• Neuropathic Pain
• Cancer Pain

Interventions

Type	Name	Description
DRUG	Protective analgesia	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.
OTHER	Pain education	Participant will receive a pain education leaflet
BEHAVIORAL	Psychological support	Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
PROCEDURE	Paravertebral block/local anaesthetic infiltration	Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
OTHER	Daily visits from pain team whilst in hospital

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-02-01
• Completion: 2018-02-01
• First posted: 2014-06-23
• Last updated: 2014-06-23

Locations

1 site across 1 country: United Kingdom