TITRE (EN) Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery
PROTOCOLE ID PLAN
CLINICAL TRIAL.gov ID NCT04874038
TYPE(S) DE CANCER Sein
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Philippe Richebé
COORDONATEUR(RICE) Nadia Godin
ngodin.hmr@ssss.gouv.qc.ca
514-252-3400 poste 3193
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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)
CRITÈRES D'EXCLUSION (EN)
  • 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)