Status:
RECRUITING
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Post-mastectomy Pain Syndrome
Breast Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 o...
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...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Exclusion
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- 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)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
- Known cirrhotic liver disease
- Pregnant
- 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)
Key Trial Info
Start Date :
September 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1602 Patients enrolled
Trial Details
Trial ID
NCT04874038
Start Date
September 22 2021
End Date
November 1 2026
Last Update
November 17 2025
Active Locations (17)
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1
Foothills Medical Centre
Calgary, Alberta, Canada
2
Sturgeon Community Hospital
Edmonton, Alberta, Canada
3
Eastern Health- Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
4
IWK
Halifax, Nova Scotia, Canada