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

NCT04874038

RecruitingPhase 3

Sponsor: University Health Network, Toronto

Conditions: Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic

Interventions: Lidocaine 20mg/ml, Placebo

Countries: Canada, Nepal, Nigeria

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)
Locations (17)
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • St. John's, Newfoundland and Labrador, Canada
  • Halifax, Nova Scotia, Canada
  • Hamilton, Ontario, Canada
  • North York, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Thunder Bay, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Dharān, Nepal
  • Ile-Ife, Nigeria