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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire [ Time Frame: 3 and 12 months ]
  3. The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale. [ Time Frame: 3 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
National Institute for Health Research, United Kingdom
Institute of Cancer Research, United Kingdom
Investigators
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Principal Investigator: JOHN E WILLIAMS, MB BS FRCA The Royal Marsden Hospital
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02170415    
Other Study ID Numbers: CCR 4116
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Royal Marsden NHS Foundation Trust:
Persistent post-surgical pain
Breast surgery
Complex intervention
Pain treatment
Additional relevant MeSH terms:
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Neuralgia
Pain, Postoperative
Cancer Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Pregabalin
Anesthetics
Anesthetics, Local
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs