Study of Intravenous Lidocaine to Prevent Long-Term Pain After Breast Cancer Surgery

What this Trial Is About

Researchers are evaluating the effect of an intravenous lidocaine infusion during breast cancer surgery to reduce the development of persistent pain three months after surgery. This international Phase III randomized controlled trial involves 1,602 patients undergoing various types of breast cancer surgery, including lumpectomy and mastectomy, and aims to compare lidocaine infusion with a placebo treatment. The study is designed to prevent long-term pain outcomes following surgery and improve patient quality of life. Participants are randomly assigned to receive either an intravenous lidocaine infusion or a placebo saline infusion during surgery. The lidocaine group receives a 1.5 mgkg bolus at the start of anesthesia, followed by a 2.0 mgkghour infusion until surgery ends and up to 30 minutes into recovery. The placebo group receives a matching saline infusion under the same conditions. Study medications are blinded and prepared in syringes to ensure unbiased treatment. Patients are monitored closely during surgery and recovery. After surgery, participants are followed up during the first three days and then at three and twelve months to assess their pain levels, use of pain medication, physical and emotional functioning, and overall quality of life. Researchers also monitor for neuropathic pain, cancer recurrence, adverse events, and cost effectiveness of the intervention. These assessments help measure the impact of lidocaine on preventing persistent pain and improving recovery over the year following surgery.

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