Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Pain, Postoperative | Pain, Chronic | Breast Cancer | Post-mastectomy Pain SyndromePhase 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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)
Study Location
Foothills Medical Centre
Foothills Medical CentreCalgary, Alberta
Canada
Contact Study Team
May Lynn Quan, MD
Juravinski Hospital
Juravinski HospitalHamilton, Ontario
Canada
Contact Study Team
James Paul, MD
Humber River Hospital
Humber River HospitalToronto, Ontario
Canada
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Sinziana Avramescu, MD
University Health Network
University Health NetworkToronto, Ontario
Canada
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Hance Clarke, MD
IWK
IWKHalifax, Nova Scotia
Canada
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Allana Munro, MD
Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences CentreThunder Bay, Ontario
Canada
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Sudhakar Subramaniam Bharathidasan, MD
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Stephen Choi, MD
Sturgeon Community Hospital
Sturgeon Community HospitalEdmonton, Alberta
Canada
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Simone Derzi, MD
North York General Hospital
North York General HospitalNorth York, Ontario
Canada
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Brian Pinchuk, MD
Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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James Khan, MD
Women's College Hospital
Women's College HospitalToronto, Ontario
Canada
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Richard Brull, MD
Eastern Health- Health Sciences Centre
Eastern Health- Health Sciences CentreSt. John's, Newfoundland and Labrador
Canada
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Geoff Zbitnew, MD
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Daniel McIsaac, MD
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Karim Ladha, MD
Hôpital Maisonneuve-Rosemont
Hôpital Maisonneuve-RosemontMontréal, Quebec
Canada
Contact Study Team
Philippe Richebe, MD
- Study Sponsored By
- University Health Network, Toronto
- Participants Required
- More Information
- Study ID:
NCT04874038