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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Sponsor: University Health Network, Toronto
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
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).
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