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RECRUITING
NCT04874038
PHASE3

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

1602

Start Date

2021-09-22

Completion Date

2026-11-01

Last Updated

2025-11-17

Healthy Volunteers

No

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).

Locations (17)

Foothills Medical Centre

Calgary, Alberta, Canada

Sturgeon Community Hospital

Edmonton, Alberta, Canada

Eastern Health- Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

IWK

Halifax, Nova Scotia, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

North York General Hospital

North York, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Humber River Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

B.P. Koirala Institute of Health Sciences

Dharān, Nepal

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Nigeria