NCT04874038

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,602 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Post-mastectomy Pain Syndrome
• Breast Cancer
• Pain, Postoperative
• Pain, Chronic

Interventions

Type	Name	Description
DRUG	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).
DRUG	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).

Timeline

• Start date: 2021-09-22
• Primary completion: 2026-03-01
• Completion: 2026-11-01
• First posted: 2021-05-05
• Last updated: 2025-11-17

Locations

17 sites across 3 countries: Canada, Nepal, Nigeria