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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of persistent pain 3-months after breast cancer surgery

Secondary outcome measures

Adverse events

Cancer Recurrence

Cost Effectiveness

+8 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

483,578 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,451,965 Total Patients Enrolled

James Khan, MDPrincipal InvestigatorUniversity Health Network, Toronto

3 Previous Clinical Trials

372 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some popular indications for Lidocaine 20mg/ml?

"Lidocaine 20mg/ml is most commonly used as an intervention for increased intra ocular pressure (iop). However, it has a variety of other potential uses such as treating nasal irritation, increasing renal excretion of toxic substances, and reducing sciatica pain."

Answered by AI

How many different medical clinics are conducting this study?

"The 12 hospitals participating in this clinical trial are the University of Alberta Hospital in Edmonton, Misericordia Community Hospital in Toronto, Humber River Hospital in Hamilton. The remaining 9 sites are located elsewhere."

Answered by AI

How can I sign up to be a part of this experiment?

"1150 individuals, aged 18 to 100 years old and who experience pain post-operatively, are needed for this study. In order to be eligible, participants must also meet the following conditions: they must be undergoing a lumpectomy or mastectomy (which can include prophylactic surgery), and this procedure must be unilateral or bilateral."

Answered by AI

Does this research require that participants be over the age of 18?

"This particular clinical trial is only looking for patients aged 18 to 100. In contrast, there are 211 other trials currently taking place that involve children and 3523 trials involving adults over the age of 65."

Answered by AI

Is this research project looking for new participants right now?

"That is accurate. The clinical trial's listing on the website indicates that it is still recruiting patients. This specific study was posted on September 22nd, 2021 and last updated February 17th, 2022. They are aiming to enroll 1,150 participants at 12 different sites."

Answered by AI

How many people are currently involved in this experiment?

"In order to move forward with this experiment, 1150 eligible individuals are needed. These potential participants must fit the bill of the inclusion criteria and can be recruited from different locations such as University of Alberta Hospital in Edmonton, Ontario and Misericordia Community Hospital in Toronto, Quebec."

Answered by AI

Has the FDA cleared Lidocaine 20mg/ml for use?

"There is both efficacy and safety data from previous clinical trials, so our team has rated the Lidocaine 20mg/ml as being a 3 on a scale of 1 to 3."

Answered by AI

Lidocaine 20mg/ml is a new medication, correct? Have there been other trials with this drug before?

"There are a total of 235 ongoing clinical trials researching the efficacy of Lidocaine 20mg/ml. Out of these, 60 are in Phase 3. Additionally, there are 1,475 different medical centres running these trials - with several being based in Duarte, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

2021. "Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04874038.

All > American Chronic Pain