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

Last updated: April 17, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Breast Cancer

Cancer

Treatment

Placebo

Lidocaine 20mg/ml

Clinical Study ID

NCT04874038
21-5021
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old

  2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of allpathologies, including prophylactic surgery (e.g., family history or BRCA genemutation)

Exclusion

Exclusion Criteria:

  1. Previous breast surgery within 6 months of index surgery

  2. Undergoing any autologous flap procedure during index surgery

  3. Presence known chronic pain disorder involving surgical site or ipsilateral chestwall, shoulder, or arm during the 3-months prior to index surgery

  4. Documented hypersensitivity or allergy to lidocaine

  5. Surgery not planned to be performed under general anesthesia and/or planned use ofregional or neuraxial anesthetic techniques before surgery (i.e., epidural,paravertebral, serratus plane block, pectoralis or modified pectoralis block)

  6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricularblock without a pacemaker

  7. Known cirrhotic liver disease

  8. Pregnant

  9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties thatwould impede valid completion of questionnaires, plans to move out of town)

Study Design

Total Participants: 1602
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 22, 2021
Estimated Completion Date:
June 01, 2026

Study Description

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus 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). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta
    Canada

    Active - Recruiting

  • Misericordia Community Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Sturgeon Community Hospital

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Eastern Health- Health Sciences Centre

    St. John's, Newfoundland and Labrador
    Canada

    Active - Recruiting

  • IWK

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • Juravinski Hospital

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario
    Canada

    Site Not Available

  • North York General Hospital

    North York, Ontario
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Active - Recruiting

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario
    Canada

    Active - Recruiting

  • Humber River Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Women's College Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Hôpital Maisonneuve-Rosemont

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Obafemi Awolowo University Teaching Hospitals Complex

    Ile-Ife,
    Nigeria

    Active - Recruiting

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