RecruitingPhase 3NCT04874038

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


Sponsor

University Health Network, Toronto

Enrollment

1,602 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving a lidocaine IV drip during breast cancer surgery can help prevent chronic (long-lasting) pain after the operation. **You may be eligible if...** - You are 18 or older - You are having a lumpectomy or mastectomy (one or both breasts), including preventive surgery - You will be under general anesthesia for the procedure **You may NOT be eligible if...** - You had breast surgery within the past 6 months - You are having a flap reconstruction using your own tissue - You have had chronic pain in the surgical area, shoulder, or arm within the last 3 months - You have a known allergy to lidocaine - You plan to have a nerve block or epidural before surgery - You have a history of serious heart rhythm problems (without a pacemaker) - You have known liver disease (cirrhosis) - You are pregnant - You are unlikely to be able to complete follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine 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).

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT04874038


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