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

Primary Purpose

Persistent Post-surgical Pain, Neuropathic Pain, Cancer Pain

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Protective analgesia
Pain education
Psychological support
Paravertebral block/local anaesthetic infiltration
Daily visits from pain team whilst in hospital
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Persistent Post-surgical Pain focused on measuring Persistent post-surgical pain, Breast surgery, Complex intervention, Pain treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention limb

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2014
Last Updated
June 20, 2014
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02170415
Brief Title
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Official Title
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Post-surgical Pain, Neuropathic Pain, Cancer Pain
Keywords
Persistent post-surgical pain, Breast surgery, Complex intervention, Pain treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention limb
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
These partcipants will receive usual care before, during and after their breast surgery
Intervention Type
Drug
Intervention Name(s)
Protective analgesia
Other Intervention Name(s)
Pregabalin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain education
Intervention Description
Participant will receive a pain education leaflet
Intervention Type
Behavioral
Intervention Name(s)
Psychological support
Intervention Description
Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
Intervention Type
Procedure
Intervention Name(s)
Paravertebral block/local anaesthetic infiltration
Intervention Description
Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
Intervention Type
Other
Intervention Name(s)
Daily visits from pain team whilst in hospital
Primary Outcome Measure Information:
Title
Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
Time Frame
3 and 12 months
Title
The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
Time Frame
3 and 12 months
Title
The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
Time Frame
3 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOHN E WILLIAMS, MB BS FRCA
Organizational Affiliation
The Royal Marsden Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

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

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