Persistent Post-surgical PainNCT02170415
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
A study testing Protective analgesia, Pain education and Psychological support in people with Persistent Post-surgical Pain and Neuropathic Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Persistent Post-surgical Pain, Neuropathic Pain, Cancer Pain
- What is being tested?
- Protective analgesia, Pain education and Psychological support
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden Hospital
London, London, SW3 6JJ
About this study
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.
Read more
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
- Being tested
- Protective analgesia, Pain education, Psychological support, Paravertebral block/local anaesthetic infiltration, Daily visits from pain team whilst in hospital
- Keywords
- Persistent post-surgical pain, Breast surgery, Complex intervention, Pain treatment
- Medical subject headings
- Neuralgia, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective analgesiaDrug
Also called Pregabalin
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.
Pain educationOther
Participant will receive a pain education leaflet
Psychological supportBehavioural
Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
Paravertebral block/local anaesthetic infiltrationProcedure or surgery
Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
Daily visits from pain team whilst in hospitalOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
Measured: 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)
Measured: 3 and 12 months
The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
Measured: 3 and 12 months
The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post-surgical PainStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- JOHN E WILLIAMS, MB BS FRCA, Principal investigator, The Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170415
- Sponsor's protocol ID
- CCR 4116
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
- ClinicalTrials.gov ID
- NCT02170415
- Acronym / sponsor ID
- CCR 4116
- Conditions
- Persistent Post-surgical Pain, Neuropathic Pain, Cancer Pain
- Keywords
- Persistent post-surgical pain, Breast surgery, Complex intervention, Pain treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Institute of Cancer Research, United Kingdom
- Study start
- Jun 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention limb | Active comparator | Drug: Protective analgesia, Other: Pain education, Behavioral: Psychological support, Procedure: Paravertebral block/local anaesthetic infiltration, Other: Daily visits from pain team whilst in hospitalMedical 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. |
| Usual care | No intervention | –These partcipants will receive usual care before, during and after their breast surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective analgesiaAlso: PregabalinParticipants 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. | Drug | Intervention limb |
| Pain educationParticipant will receive a pain education leaflet | Other | Intervention limb |
| Psychological supportParticipants demonstrating psychological morbidity will be offered psychological support prior to surgery | Behavioural | Intervention limb |
| Paravertebral block/local anaesthetic infiltrationPatients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated | Procedure or surgery | Intervention limb |
| Daily visits from pain team whilst in hospital | Other | Intervention limb |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOHN E WILLIAMS, MB BS FRCA principal investigator
The Royal Marsden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective analgesia, Pain education and Psychological support in people with Persistent Post-surgical Pain and Neuropathic Pain, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.