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Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a\u00a0lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5\u00a0mg\/kg with induction of anesthesia, followed by a 2.0\u00a0mg\/kg\/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1\u20133\u00a0days, and 12\u00a0months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08151-4","type":"journal-article","created":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T03:38:30Z","timestamp":1716349110000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1210-7545","authenticated-orcid":false,"given":"James S.","family":"Khan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Gilron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. 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DeGroote Institute of Pain Research and Care which supported the initial pilot for this trial.IG\u2014reports consulting honoraria from Combigene, GW Research, Lilly and Novaremed.KK\u2014Supported in part by a merit award from the Department of Anesthesia and Pain Medicine, University of Toronto-Research support and\/or consultancy for Octapharma and Instrumentation Laboratory.KSL\u2014Co-PI of an observational study on medical cannabis funded by Shoppers Drug Mart.DWL\u2014Consultant with Merck Canada Inc., Speaker fees from Mayo Clinic foundation (2022).PR\u2014Has received several Investigator Initiated Trial grants from companies who were funders of the trials whereas my research center was the sponsor. These grants had a contract between our attorneys of our research institution and companies to make sure the PI remained totally independent form companies who were only funders (no right on data, no right on publications). Gave educational lectures for companies and received some honorarium (Medtronic, Medasense Ltd, Merck, Avirpharma).NJLK\u2014Consultant for MOLLI Surgical.JWB\u2014Supported, in part, by a Canadian Institutes of Health Research Canada Research Chair in the prevention and management of chronic pain.MS\u2014Currently holds the Canadian Anesthesiologists\u2019 Society Career Scientist Grant and a Merit award from the Department of Anesthesiology and Pain Medicine, University of Toronto (Toronto, Canada) to support academic time. Dr. Singh also serves on the Medical Advisory Board of Hypersomnia Foundation (Atlanta, GA) at a voluntary basis.PJD\u2014Has received grant funding from the following companies: Abbott Diagnostics, Roche Diagnostics, Siemens. He has received medical devices for trials from the following company: CloudDX. He is a consultant for: Abbott Canada, Renibus, Roche Canada, Trimedic. He is a member of advisory boards to: Bayer and Quidel. He was a speaker for the following company: Velocity.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"337"}}