Evaluating Lidocaine Infusions to Reduce Chronic Pain After Breast Cancer Surgery in Adult Women

What this Trial Is About

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery to reduce moderate or severe chronic post-surgical pain in adult women undergoing elective breast cancer surgery. This large, international, randomized, double-blind trial aims to detect a meaningful reduction in chronic pain one year after surgery and also assesses safety, pain relief, opioid use, nerve-related pain symptoms, psychological health, and quality of life. Participants receive either a lidocaine infusion starting with an intravenous bolus after anesthesia induction, continuing with an intraoperative intravenous infusion, and followed by a post-operative subcutaneous infusion for up to 24 hours. The lidocaine dosing is adjusted by lean body weight with a cap, while the comparison group receives a saline placebo infusion following the same schedule. Day-case surgeries receive only the intraoperative treatments without the post-operative infusion. During the trial, participants will be monitored for pain severity, opioid consumption, nerve-related symptoms, psychological distress, physical functioning, quality of life, safety events, and health care costs up to one year after surgery. The primary outcome is the incidence of moderate or severe chronic post-surgical pain reported at one year. Assessments include patient-reported outcomes, pain scores at 24 hours postoperatively, and opioid use at various timepoints. The total participation duration extends up to one year after surgery.

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial