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Local Anesthetic

Lidocaine for Postoperative Pain in Breast Cancer

Phase 3
Recruiting
Led By James Khan, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
Undergoing any autologous flap procedure during index surgery
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 12 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether or not lidocaine reduces persistent pain after breast cancer surgery.

Who is the study for?
This trial is for adults over 18 who are having breast cancer surgery (lumpectomy or mastectomy) for any reason, including high risk without current cancer. It's not for those with recent breast surgery, chronic pain at the site, lidocaine allergy, certain heart conditions, liver disease, pregnancy or if they can't follow up.
What is being tested?
The PLAN trial is testing whether giving an IV infusion of Lidocaine during breast cancer surgery can prevent long-term pain after the operation. Participants will be randomly assigned to receive either Lidocaine or a placebo in a blinded setup.
What are the potential side effects?
Lidocaine may cause side effects such as allergic reactions, nerve issues like tingling or numbness and rarely heart problems. However, since it's given intravenously and monitored closely during surgery risks are minimized.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am having a lumpectomy or mastectomy, for any reason including prevention.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having surgery using my own tissue for reconstruction.
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My surgery will not use general anesthesia but may use local or regional anesthesia.
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I have been diagnosed with cirrhosis of the liver.
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I have had heart rhythm problems without a pacemaker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Development of persistent pain 3-months after breast cancer surgery
Secondary study objectives
Adverse events
Cancer Recurrence
Cost Effectiveness
+8 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Intraoperative intravenous lidocaine/placebo infusion
Group II: ControlPlacebo Group1 Intervention
Intraoperative intravenous lidocaine/placebo infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine 20mg/ml
2016
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
502,720 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,525,864 Total Patients Enrolled
James Khan, MDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
372 Total Patients Enrolled
PJ Devereaux, MD.PhDPrincipal InvestigatorPopulation Health Research Institute
Ian Gilron, MDPrincipal InvestigatorQueen's University

Media Library

Lidocaine 20mg/ml (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04874038 — Phase 3
Post Mastectomy Pain Syndrome Research Study Groups: Intervention, Control
Post Mastectomy Pain Syndrome Clinical Trial 2023: Lidocaine 20mg/ml Highlights & Side Effects. Trial Name: NCT04874038 — Phase 3
Lidocaine 20mg/ml (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04874038 — Phase 3
~182 spots leftby Jun 2025
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