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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Lidocaine

Criteria

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)