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

NCT04874038 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1602

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Post-mastectomy Pain Syndrome
  • Breast Cancer
  • Pain, Postoperative
  • Pain, Chronic

Interventions

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).

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).

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • James Khan, MD · University Health Network, Toronto

  • PJ Devereaux, MD.PhD · Population Health Research Institute

  • Ian Gilron, MD · Kingston Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2026-03-01
Completion
2026-11-01

Countries

  • Canada
  • Nepal
  • Nigeria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04874038 on ClinicalTrials.gov