Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
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|ClinicalTrials.gov Identifier: NCT02170415|
Recruitment Status : Unknown
Verified June 2014 by Royal Marsden NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Persistent Post-surgical Pain Neuropathic Pain Cancer Pain||Drug: Protective analgesia Other: Pain education Behavioral: Psychological support Procedure: Paravertebral block/local anaesthetic infiltration Other: Daily visits from pain team whilst in hospital||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2018|
Active Comparator: Intervention limb
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
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 Name: Pregabalin
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
No Intervention: Usual care
These partcipants will receive usual care before, during and after their breast surgery
- 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 ]
- 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 ]
- The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire [ Time Frame: 3 and 12 months ]
- The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale. [ Time Frame: 3 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170415
|The Royal Marsden Hospital|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||JOHN E WILLIAMS, MB BS FRCA||The Royal Marsden Hospital|