Actively Recruiting

Phase 3
Age: 18Years - 100Years
All Genders
NCT04874038

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

Led by University Health Network, Toronto · Updated on 2025-11-17

1602

Participants Needed

17

Research Sites

266 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Undergoing unilateral or bilateral lumpectomy or mastectomy for any pathology, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Not Eligible

You will not qualify if you...

  • Previous breast surgery within 6 months before the planned surgery
  • Undergoing any autologous flap procedure during the planned surgery
  • Known chronic pain disorder affecting the surgical site, chest wall, shoulder, or arm on the same side within 3 months before surgery
  • Documented allergy or hypersensitivity to lidocaine
  • Surgery not planned under general anesthesia or planned use of regional or neuraxial anesthesia before surgery
  • History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
  • Known cirrhotic liver disease
  • Pregnant
  • Unlikely to comply with follow-up due to no fixed address, language difficulties, or plans to move away

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Foothills Medical Centre

Calgary, Alberta, Canada

Actively Recruiting

2

Sturgeon Community Hospital

Edmonton, Alberta, Canada

Actively Recruiting

3

Eastern Health- Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Actively Recruiting

4

IWK

Halifax, Nova Scotia, Canada

Actively Recruiting

5

Juravinski Hospital

Hamilton, Ontario, Canada

Actively Recruiting

6

North York General Hospital

North York, Ontario, Canada

Actively Recruiting

7

The Ottawa Hospital

Ottawa, Ontario, Canada

Actively Recruiting

8

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Actively Recruiting

9

Humber River Hospital

Toronto, Ontario, Canada

Actively Recruiting

10

Mount Sinai Hospital

Toronto, Ontario, Canada

Actively Recruiting

11

St. Michael's Hospital

Toronto, Ontario, Canada

Actively Recruiting

12

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Actively Recruiting

13

University Health Network

Toronto, Ontario, Canada

Actively Recruiting

14

Women's College Hospital

Toronto, Ontario, Canada

Actively Recruiting

15

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Actively Recruiting

16

B.P. Koirala Institute of Health Sciences

Dharān, Nepal

Actively Recruiting

17

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Nigeria

Actively Recruiting

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Research Team

J

James Khan

CONTACT

N

Nour Ayach

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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