A Phase 3 interventional study of Lidocaine 20mg/ml and Placebo in Post-mastectomy Pain Syndrome, Breast Cancer and Pain, Postoperative, sponsored by University Health Network, Toronto. Active, not recruiting at 17 sites in 3 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Prevention
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.
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 1,604 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intraoperative intravenous lidocaine/placebo infusion
Drug: Lidocaine 20mg/ml
Intraoperative intravenous lidocaine/placebo infusion
Drug: Placebo
Drug page: Lidocaine
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).
Also known as: Lidocaine 2%
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).
Also known as: 0.9% sodium chloride solution
Development of persistent pain 3-months after breast cancer surgery
Persistent pain at 3-months
Time frame: 3- months
Pain intensities
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Time frame: 3 and 12 months
Opioid consumption
Morphine-equivalent opioid consumption
Time frame: 3 and 12 months
Moderate-to-severe persistent pain
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Time frame: 3 and 12 months
Persistent neuropathic pain
Measured using the Douleur Neuropathique 4-symptoms interview
Time frame: 3 and 12 months
Sensory and affective qualities of pain
Quality of pain is reported using the Short Form McGill Pain Questionnaire
Time frame: 3 and 12 months
Emotional functioning
Emotional functioning is reported using the Profile of Mood States (POMS)
Time frame: 3 and 12 months
Physical functioning
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Time frame: 3 and 12 months
Health-related quality of life quality of life
Health-related quality of life will be assessed using EQ-5D-5L
Time frame: 3 and 12 months
Cancer Recurrence
Cancer recurrence will be assessed as a secondary outcome
Time frame: 3 and 12 months
Adverse events
Adverse Events will be monitored as a secondary safety outcome
Time frame: 3 and 12 months
Cost Effectiveness
Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
Time frame: 3 months
Plan to share: No
Ran from Sep 2021 to primary completion in Apr 2026, 55 months.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's 55 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
Completion moved once since we started tracking on Sep 25, 2026: Nov 2026 → May 2027, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
University Health Network, Toronto →