Recruiting
Phase 3

Lidocaine

Sponsor:

University Health Network, Toronto

Code:

NCT04874038

Conditions

Post-mastectomy Pain Syndrome

Breast Cancer

Pain, Postoperative

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lidocaine 20mg/ml

Placebo

Study Details

Brief 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.

Conditions

Post-mastectomy Pain Syndrome

Breast Cancer

Pain, Postoperative

Pain, Chronic

Study ID

NCT04874038

Start date

Sep 22, 2021

Status verified date

Jun, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Apr 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years old
2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

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 chest wall, 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 of regional 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 atrioventricular block without a pacemaker
7. Known cirrhotic liver disease
8. Pregnant
9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)

Study Design

Enrollment

1602 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Intraoperative intravenous lidocaine/placebo infusion

placebo comparator: Control

Intraoperative intravenous lidocaine/placebo infusion

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).

Primary outcome measure

  • Development of persistent pain 3-months after breast cancer surgery [ Time Frame: 3- months ]

Central Contacts and Locations

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Sturgeon Community Hospital

Recruiting

Edmonton, Alberta, Canada

Eastern Health- Health Sciences Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada

IWK

Recruiting

Halifax, Nova Scotia, Canada

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada

North York General Hospital

Recruiting

North York, Ontario, Canada

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada

Humber River Hospital

Recruiting

Toronto, Ontario, Canada

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

University Health Network

Recruiting

Toronto, Ontario, Canada

Women's College Hospital

Recruiting

Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-22.