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

Titre officiel

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

Sommaire:

Essai international multicentrique contrôlé de phase III, avec répartition aléatoire 1:1, en groupes parallèles, en insu, visant à déterminer l’effet d’une perfusion peropératoire de lidocaïne sur la réduction de l’apparition de la douleur persistante 3 mois après une chirurgie du cancer du sein.

Description de l'essai

Primary Outcome:

• Development of persistent pain 3-months after breast cancer surgery

Secondary Outcome:

• Pain intensities
• Opioid consumption
• Moderate-to-severe persistent pain
• Persistent neuropathic pain
• Sensory and affective qualities of pain
• Emotional functioning
• Physical functioning
• Health-related quality of life quality of life
• Cancer Recurrence
• Adverse events

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,150 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Voir cet essai sur ClinicalTrials.gov