Post-mastectomy Pain SyndromePhase 3PLANNCT02240199
Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
A Phase 3 study testing Intraoperative Intravenous Lidocaine Infusion and Perioperative Pregabalin in people with Post-mastectomy Pain Syndrome and Chronic Post-surgical Pain, run by McMaster University at 2 sites in Canada.
Trial summary
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome, Chronic Post-surgical Pain
- What is being tested?
- Intraoperative Intravenous Lidocaine Infusion and Perioperative Pregabalin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2014to Jan 2016
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients 18-75 years of age
- undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast conserving surgery), for prophylactic (e.g. family history or BRCA gene mutation) or belief of isolated (non-metastatic) cancerous lesions
- receiving a general anesthetic
Who cannot join
- previous breast surgery within six months of index surgery
- undergoing a DIEP (Deep Inferior Epigastric Perforator) flap procedure
- patient has chronic pain or a chronic pain syndrome for which they have taken 4 or more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic, anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve blocks) during the past 3 months
- documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine
- history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block ≥ type II
- history of congestive heart failure
Show all 14Show fewer
- renal insufficiency with creatinine > 120 µmol/L
- known or previously documented cirrhosis
- pregnant
- unable to swallow study medications
- patient's surgeon believes patient is inappropriate for inclusion in trial
- unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)
- language difficulties that would impede valid completion of questionnaires
- patient requires gabapentin or pregabalin for a medical condition or has been taking gabapentin or pregabalin daily during the past 1 week
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. Patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. Chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. There is encouraging data suggesting that an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. A large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to determine the feasibility of undertaking such a trial.
- Being tested
- Intraoperative Intravenous Lidocaine Infusion, Perioperative Pregabalin, Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Intravenous Lidocaine InfusionDrug
Also called Xylocaine
Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
Perioperative PregabalinDrug
Also called Lyrica
Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
Perioperative Pregabalin PlaceboDrug
Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
Intraoperative Intravenous Lidocaine Placebo InfusionDrug
Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin/Lidocaine | Experimental | Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion Receives: Drug: Intraoperative Intravenous Lidocaine Infusion; Drug: Perioperative Pregabalin |
| Pregabalin Placebo/Lidocaine | Active comparator | Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion Receives: Drug: Intraoperative Intravenous Lidocaine Infusion; Drug: Perioperative Pregabalin Placebo |
| Pregabalin/Lidocaine Placebo | Active comparator | Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion Receives: Drug: Perioperative Pregabalin; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion |
| Pregabalin Placebo/Lidocaine Placebo | Placebo comparator | Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion Receives: Drug: Perioperative Pregabalin Placebo; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.
Measured: 6 months
Secondary outcomes (5)
Post-mastectomy pain syndrome
Measured: 6 months
Length of hospital stay
Most breast cancer surgeries are day procedures, therefore length of hospital stay will be measured based on whether or not the patient was discharged from the hospital on the same day as surgery or if they were admitted and remained in hospital overnight.
Measured: Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
Quality of Life
Measured: 3 months
Somatic Pre-occupation and Coping Scale
Measured: 3 months
Acute postoperative pain
Measured: Postoperative days 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- James S Khan, BHSc, MD, Study director, Population Health Research InstituteP.J. Devereaux, MD, PhD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240199
- Sponsor's protocol ID
- PLAN14001
- Acronym
- PLAN
- Status last verified
- Dec 2016
- First submitted
- 19 Aug 2014
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Khan JS, Hodgson N, Choi S, Reid S, Paul JE, Hong NJL, Holloway C, Busse JW, Gilron I, Buckley DN, McGillion M, Clarke H, Katz J, Mackey S, Avram R, Pohl K, Rao-Melacini P, Devereaux PJ. Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial. J Pain. 2019 Aug;20(8):980-993. doi: 10.1016/j.jpain.2019.02.010. Epub 2019 Mar 5.
PubMed 30844507
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
- ClinicalTrials.gov ID
- NCT02240199
- Acronym / sponsor ID
- PLAN / PLAN14001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Sep 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.
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. Patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. Chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. There is encouraging data suggesting that an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. A large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to determine the feasibility of undertaking such a trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin/Lidocaine | Experimental | Drug: Intraoperative Intravenous Lidocaine Infusion, Drug: Perioperative PregabalinPerioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion |
| Pregabalin Placebo/Lidocaine | Active comparator | Drug: Intraoperative Intravenous Lidocaine Infusion, Drug: Perioperative Pregabalin PlaceboPerioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion |
| Pregabalin/Lidocaine Placebo | Active comparator | Drug: Perioperative Pregabalin, Drug: Intraoperative Intravenous Lidocaine Placebo InfusionPerioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion |
| Pregabalin Placebo/Lidocaine Placebo | Placebo comparator | Drug: Perioperative Pregabalin Placebo, Drug: Intraoperative Intravenous Lidocaine Placebo InfusionPerioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients 18-75 years of age
- undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast conserving surgery), for prophylactic (e.g. family history or BRCA gene mutation) or belief of isolated (non-metastatic) cancerous lesions
- receiving a general anesthetic
Key exclusion criteria (14 listed)
- previous breast surgery within six months of index surgery
- undergoing a DIEP (Deep Inferior Epigastric Perforator) flap procedure
- patient has chronic pain or a chronic pain syndrome for which they have taken 4 or more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic, anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve blocks) during the past 3 months
- documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine
- history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block ≥ type II
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 |
|---|---|---|
| Intraoperative Intravenous Lidocaine InfusionAlso: XylocaineLidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure. | Drug | Pregabalin Placebo/Lidocaine, Pregabalin/Lidocaine |
| Perioperative PregabalinAlso: LyricaPregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery. | Drug | Pregabalin/Lidocaine, Pregabalin/Lidocaine Placebo |
| Perioperative Pregabalin PlaceboPregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery. | Drug | Pregabalin Placebo/Lidocaine, Pregabalin Placebo/Lidocaine Placebo |
| Intraoperative Intravenous Lidocaine Placebo InfusionLidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure. | Drug | Pregabalin Placebo/Lidocaine Placebo, Pregabalin/Lidocaine Placebo |
Primary outcome
Feasibility
Time frame: 6 months
The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.
5 secondary outcomes
Post-mastectomy pain syndrome
Time frame: 6 months
Length of hospital stay
Time frame: Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
Quality of Life
Time frame: 3 months
Somatic Pre-occupation and Coping Scale
Time frame: 3 months
Acute postoperative pain
Time frame: Postoperative days 1-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 30844507Khan JS, Hodgson N, Choi S, Reid S, Paul JE, Hong NJL, Holloway C, Busse JW, Gilron I, Buckley DN, McGillion M, Clarke H, Katz J, Mackey S, Avram R, Pohl K, Rao-Melacini P, Devereaux PJ. Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial. J Pain. 2019 Aug;20(8):980-993. doi: 10.1016/j.jpain.2019.02.010. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No
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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.
James S Khan, BHSc, MD study director
Population Health Research Institute
P.J. Devereaux, MD, PhD principal investigator
Population Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intraoperative Intravenous Lidocaine Infusion and Perioperative Pregabalin in people with Post-mastectomy Pain Syndrome and Chronic Post-surgical Pain, run by McMaster University at 2 sites in Canada.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240199, which also lists 1 linked publication.
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 24 Apr 2018.