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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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)

Where this trial is running

• Foothills Medical Centre, Calgary, Alberta, Canada
• Sturgeon Community Hospital, Edmonton, Alberta, Canada
• Eastern Health- Health Sciences Centre, St. John's, Newfoundland and Labrador, Canada
• IWK, Halifax, Nova Scotia, Canada
• Juravinski Hospital, Hamilton, Ontario, Canada
• North York General Hospital, North York, Ontario, Canada
• The Ottawa Hospital, Ottawa, Ontario, Canada
• Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
• Humber River Hospital, Toronto, Ontario, Canada
• Mount Sinai Hospital, Toronto, Ontario, Canada
• St. Michael's Hospital, Toronto, Ontario, Canada
• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

+ 5 more sites.

Who to contact

James Khan · 416-340-4800 · James.Khan@medportal.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04874038.