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

NCT02170415 | Unknown DMC

• 1 other identifier: CCR 4116
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Persistent post-surgical pain; Breast surgery; Complex intervention; Pain treatment

Outcome Measures

Primary Outcomes (1)

• Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.

  3 months

Secondary Outcomes (3)

• The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)

  3 and 12 months

• The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire

  3 and 12 months

• The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.

  3 and 12 months

Study Arms (2)

Intervention limb

ACTIVE COMPARATOR

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.

Drug: Protective analgesia; Other: Pain education; Behavioral: Psychological support; Procedure: Paravertebral block/local anaesthetic infiltration; Other: Daily visits from pain team whilst in hospital

Usual care

NO INTERVENTION

These partcipants will receive usual care before, during and after their breast surgery

Interventions

Protective analgesia DRUG

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.

Also known as: Pregabalin

Intervention limb

Pain education OTHER

Participant will receive a pain education leaflet

Intervention limb

Psychological support BEHAVIORAL

Participants demonstrating psychological morbidity will be offered psychological support prior to surgery

Intervention limb

Paravertebral block/local anaesthetic infiltration PROCEDURE

Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated

Intervention limb

Daily visits from pain team whilst in hospital OTHER

Intervention limb

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

The Royal Marsden Hospital

London, London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia; Cancer Pain; Agnosia

Interventions

Pregabalin; Hospitals

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• JOHN E WILLIAMS, MB BS FRCA

  The Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

GB (1)