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

June 17, 2026 updated by: University Health Network, Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1602

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Foothills Medical Centre
        • Contact:
          • May Lynn Quan, MD
      • Edmonton, Alberta, Canada
        • Recruiting
        • Sturgeon Community Hospital
        • Contact:
          • Simone Derzi, MD
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Recruiting
        • Eastern Health- Health Sciences Centre
        • Contact:
          • Geoff Zbitnew, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • IWK
        • Contact:
          • Allana Munro, MD
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Hospital
        • Contact:
          • James Paul, MD
      • North York, Ontario, Canada
        • Recruiting
        • North York General Hospital
        • Contact:
          • Brian Pinchuk, MD
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital
        • Contact:
          • Daniel McIsaac, MD
      • Thunder Bay, Ontario, Canada
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
          • Sudhakar Subramaniam Bharathidasan, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • James Khan, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
          • Stephen Choi, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • University Health Network
        • Contact:
          • Hance Clarke, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Karim Ladha, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Humber River Hospital
        • Contact:
          • Sinziana Avramescu, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Women's College Hospital
        • Contact:
          • Richard Brull, MD
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Hopital Maisonneuve-Rosemont
        • Contact:
          • Philippe Richebe, MD
  • Nepal
      • Dharān, Nepal
        • Recruiting
        • B.P. Koirala Institute of Health Sciences
  • Nigeria
      • Ile-Ife, Nigeria
        • Recruiting
        • Obafemi Awolowo University Teaching Hospitals Complex
        • Contact:
          • Funmilola Wuraola, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

Exclusion Criteria:

  1. Previous breast surgery within 6 months of index surgery
  2. Undergoing any autologous flap procedure during index surgery
  3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
  4. Documented hypersensitivity or allergy to lidocaine
  5. 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)
  6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
  7. Known cirrhotic liver disease
  8. Pregnant
  9. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Intraoperative intravenous lidocaine/placebo infusion
Drug: Lidocaine 20mg/ml
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).
Other Names:
  • Lidocaine 2%
Placebo Comparator: Control
Intraoperative intravenous lidocaine/placebo infusion
Drug: Placebo
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).
Other Names:
  • 0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development of persistent pain 3-months after breast cancer surgery
Time Frame: 3- months
Persistent pain at 3-months
3- months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensities
Time Frame: 3 and 12 months
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
3 and 12 months
Opioid consumption
Time Frame: 3 and 12 months
Morphine-equivalent opioid consumption
3 and 12 months
Moderate-to-severe persistent pain
Time Frame: 3 and 12 months
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
3 and 12 months
Persistent neuropathic pain
Time Frame: 3 and 12 months
Measured using the Douleur Neuropathique 4-symptoms interview
3 and 12 months
Sensory and affective qualities of pain
Time Frame: 3 and 12 months
Quality of pain is reported using the Short Form McGill Pain Questionnaire
3 and 12 months
Emotional functioning
Time Frame: 3 and 12 months
Emotional functioning is reported using the Profile of Mood States (POMS)
3 and 12 months
Physical functioning
Time Frame: 3 and 12 months
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
3 and 12 months
Health-related quality of life quality of life
Time Frame: 3 and 12 months
Health-related quality of life will be assessed using EQ-5D-5L
3 and 12 months
Cancer Recurrence
Time Frame: 3 and 12 months
Cancer recurrence will be assessed as a secondary outcome
3 and 12 months
Adverse events
Time Frame: 3 and 12 months
Adverse Events will be monitored as a secondary safety outcome
3 and 12 months
Cost Effectiveness
Time Frame: 3 months
Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Khan, MD, University Health Network, Toronto
  • Principal Investigator: PJ Devereaux, MD.PhD, Population Health Research Institute
  • Principal Investigator: Ian Gilron, MD, Kingston Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-5021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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