Post-mastectomy Pain SyndromePhase 3NCT04874038
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
A Phase 3 study testing Lidocaine 20mg/ml in people with Post-mastectomy Pain Syndrome and Breast Cancer, run by University Health Network, Toronto at 17 sites in 3 countries.
Trial summary
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative
- What is being tested?
- Lidocaine 20mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,604 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 22 Sep 2021to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Who cannot join
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
Show all 9Show fewer
- Known cirrhotic liver disease
- Pregnant
- Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Canada15 sites
Foothills Medical Centre
Calgary, Alberta
Sturgeon Community Hospital
Edmonton, Alberta
IWK
Halifax, Nova Scotia
Juravinski Hospital
Hamilton, Ontario
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
North York General Hospital
North York, Ontario
The Ottawa Hospital
Ottawa, Ontario
Eastern Health- Health Sciences Centre
St. John's, Newfoundland and Labrador
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Humber River Hospital
Toronto, Ontario
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
University Health Network
Toronto, Ontario
Women's College Hospital
Toronto, Ontario
About this study
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
Read the detailed description
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes
- Being tested
- Lidocaine 20mg/ml, Placebo
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 20mg/mlDrug
Also called Lidocaine 2%
Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
PlaceboDrug
Also called 0.9% sodium chloride solution
Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intraoperative intravenous lidocaine/placebo infusion Receives: Drug: Lidocaine 20mg/ml |
| Control | Placebo comparator | Intraoperative intravenous lidocaine/placebo infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of persistent pain 3-months after breast cancer surgery
Persistent pain at 3-months
Measured: 3- months
Secondary outcomes (11)
Pain intensities
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Measured: 3 and 12 months
Opioid consumption
Morphine-equivalent opioid consumption
Measured: 3 and 12 months
Moderate-to-severe persistent pain
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Measured: 3 and 12 months
Persistent neuropathic pain
Measured using the Douleur Neuropathique 4-symptoms interview
Measured: 3 and 12 months
Sensory and affective qualities of pain
Quality of pain is reported using the Short Form McGill Pain Questionnaire
Measured: 3 and 12 months
Emotional functioning
Emotional functioning is reported using the Profile of Mood States (POMS)
Measured: 3 and 12 months
Physical functioning
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Measured: 3 and 12 months
Health-related quality of life quality of life
Health-related quality of life will be assessed using EQ-5D-5L
Measured: 3 and 12 months
Cancer Recurrence
Cancer recurrence will be assessed as a secondary outcome
Measured: 3 and 12 months
Adverse events
Adverse Events will be monitored as a secondary safety outcome
Measured: 3 and 12 months
Cost Effectiveness
Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start22 Sep 2021
- Primary completion30 Apr 2026
- Study completion1 May 2027 (estimated)
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 University Health Network, TorontoThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- James Khan, MD, Principal investigator, University Health Network, TorontoPJ Devereaux, MD.PhD, Principal investigator, Population Health Research InstituteIan Gilron, MD, Principal investigator, Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874038
- Sponsor's protocol ID
- 21-5021
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan JS, Gilron I, Devereaux PJ, Clarke H, Ayach N, Tomlinson G, Quan ML, Ladha KS, Choi S, Munro A, Brull R, Lim DW, Avramescu S, Richebe P, Hodgson N, Paul J, McIsaac DI, Derzi S, Zbitnew GL, Easson AM, Siddiqui NT, Miles SJ, Karkouti K; PLAN Trial Investigators. Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial. Trials. 2024 May 22;25(1):337. doi: 10.1186/s13063-024-08151-4.
PubMed 38773653
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
- ClinicalTrials.gov ID
- NCT04874038
- Acronym / sponsor ID
- 21-5021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,604 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 May 2021 (actual)
- 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.
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
Detailed description
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Lidocaine 20mg/mlIntraoperative intravenous lidocaine/placebo infusion |
| Control | Placebo comparator | Drug: PlaceboIntraoperative intravenous lidocaine/placebo infusion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Key exclusion criteria (9 listed)
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
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 |
|---|---|---|
| Lidocaine 20mg/mlAlso: Lidocaine 2%Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). | Drug | Intervention |
| PlaceboAlso: 0.9% sodium chloride solutionPatients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room). | Drug | Control |
Primary outcome
Development of persistent pain 3-months after breast cancer surgery
Time frame: 3- months
Persistent pain at 3-months
11 secondary outcomes
Pain intensities
Time frame: 3 and 12 months
Opioid consumption
Time frame: 3 and 12 months
Moderate-to-severe persistent pain
Time frame: 3 and 12 months
Persistent neuropathic pain
Time frame: 3 and 12 months
Sensory and affective qualities of pain
Time frame: 3 and 12 months
Emotional functioning
Time frame: 3 and 12 months
Physical functioning
Time frame: 3 and 12 months
Health-related quality of life quality of life
Time frame: 3 and 12 months
Cancer Recurrence
Time frame: 3 and 12 months
Adverse events
Time frame: 3 and 12 months
Cost Effectiveness
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 38773653Khan JS, Gilron I, Devereaux PJ, Clarke H, Ayach N, Tomlinson G, Quan ML, Ladha KS, Choi S, Munro A, Brull R, Lim DW, Avramescu S, Richebe P, Hodgson N, Paul J, McIsaac DI, Derzi S, Zbitnew GL, Easson AM, Siddiqui NT, Miles SJ, Karkouti K; PLAN Trial Investigators. Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial. Trials. 2024 May 22;25(1):337. doi: 10.1186/s13063-024-08151-4.
- 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 Khan, MD principal investigator
University Health Network, Toronto
PJ Devereaux, MD.PhD principal investigator
Population Health Research Institute
Ian Gilron, MD principal investigator
Kingston Health Sciences Centre
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 20mg/ml in people with Post-mastectomy Pain Syndrome and Breast Cancer, run by University Health Network, Toronto at 17 sites in 3 countries.
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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, Nepal, Nigeria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Development of persistent pain 3-months after breast cancer surgery (time frame: 3- 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 NCT04874038, 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 25 Sep 2026.