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

What this Trial Is About

Researchers are evaluating the long-term effects of lidocaine infusions started during surgery and continued for up to 24 hours after surgery on moderate or severe chronic post-surgical pain CPSP one year after elective breast cancer surgery in adult female patients. This large, international, randomized, double-blind, placebo-controlled study aims to determine if lidocaine can reduce the incidence of CPSP by 25. The study also assesses safety, pain relief, opioid use, neuropathic pain features, psychological wellbeing, and quality of life outcomes. The study compares two groups one receiving lidocaine infusions and the other receiving placebo saline infusions. Lidocaine is given as an intravenous bolus after anesthesia induction, followed by an intravenous infusion during surgery, and then a subcutaneous infusion postoperatively for up to 24 hours. The placebo group receives matching saline solutions in the same schedule. Day-case surgeries receive only the intraoperative bolus and infusion without the postoperative infusion. Participants will be followed for one year after surgery to assess the presence and severity of CPSP, pain characteristics, opioid consumption at multiple time points, physical function, psychological distress, quality of life changes, and healthcare costs. Safety events and mortality at one year are also tracked. Assessments include patient-reported pain and symptom scores, psychological questionnaires, and health economic measures. The total participation duration is one year post-surgery.

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