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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02170415
• Other study ID #: CCR 4116
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2014
• Last updated: June 20, 2014
• Start date: June 2014
• Est. completion date: February 2018

Study information

• Verified date: June 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer Pain
• Neuralgia
• Neuropathic Pain
• Pain, Postoperative
• Persistent Post-surgical Pain

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.		3 months	No
Secondary	The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)		3 and 12 months	No
Secondary	The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire		3 and 12 months	No
Secondary	The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.		3 and 12 months	No