Titre |
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery |
Protocole ID |
PLAN |
ClinicalTrials.gov ID |
NCT04874038 |
Type(s) de cancer |
Sein |
Phase |
Phase III |
Type étude |
Clinique |
Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Philippe Richebé
|
Coordonnateur(trice) |
Nadia Godin
514-252-3400 poste 3193
|
Statut |
Actif en recrutement |
Critètes d'éligibilité |
- 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)
|
Critètes d'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)
|