Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial
James S. Khan,
Ian Gilron,
P. J. Devereaux,
Hance Clarke,
Nour Ayach,
George Tomlinson,
May Lynn Quan,
Karim S. Ladha,
Stephen Choi,
Allana Munro,
Richard Brull,
David W. Lim,
Sinziana Avramescu,
Philippe Richebé,
Nicole Hodgson,
James Paul,
Daniel I. McIsaac,
Simone Derzi,
Geoff L. Zbitnew,
Alexandra M. Easson,
Naveed T. Siddiqui,
Sarah J. Miles,
Keyvan Karkouti,
PLAN Trial Investigators
Affiliations
James S. Khan
Department of Anesthesiology & Pain Medicine, Mount Sinai Hospital, University of Toronto
Ian Gilron
Departments of Anesthesiology & Perioperative Medicine, and Biomedical & Molecular Sciences, Centre for Neuroscience Studies, and School of Policy Studies, Queen’s University and Kingston Health Sciences Centre
P. J. Devereaux
Population Health Research Institute, McMaster University, Hamilton Health Sciences Corporation
Hance Clarke
Department of Anesthesiology and Pain Medicine, University of Toronto
Nour Ayach
Department of Anesthesiology & Pain Medicine, University of Toronto
George Tomlinson
Department of Medicine, University Health Network and Mount Sinai Hospital
May Lynn Quan
Department of Surgery/Oncology, University of Calgary
Karim S. Ladha
Department of Anesthesiology and Pain Medicine, University of Toronto
Stephen Choi
Department of Anesthesiology and Pain Medicine, Sunnybrook Health Sciences Centre, University of Toronto
Allana Munro
Department of Anesthesia, Pain Management, and Perioperative Medicine, Dalhousie University
Richard Brull
Department of Anesthesiology and Pain Medicine, Women’s College Hospital, University of Toronto
David W. Lim
Women’s College Research Institute & Department Surgery, Women’s College Hospital
Sinziana Avramescu
Department of Anesthesiology and Pain Medicine, Humber River Hospital, University of Toronto
Philippe Richebé
Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital, CIUSSS de L’Est de L’Ile de Montreal (CEMTL), University of Montreal
Nicole Hodgson
Department of Surgery, McMaster University
James Paul
Department of Anesthesia, McMaster University
Daniel I. McIsaac
Departments of Anesthesiology & Pain Medicine and School of Epidemiology & Public Health, The Ottawa Hospital, University of Ottawa
Simone Derzi
Department of Anesthesiology & Pain Medicine, University of Alberta
Geoff L. Zbitnew
Department of Anesthesiology, Memorial University
Alexandra M. Easson
Department of Surgery and Institute of Health, Policy, Management and Evaluation (HPME), Mount Sinai Hospital and Princess Margaret Cancer Centre, University of Toronto
Naveed T. Siddiqui
Department of Anesthesiology & Pain Medicine, Mount Sinai Hospital, University of Toronto
Sarah J. Miles
Department of Anesthesia and Pain Medicine, University of Toronto
Keyvan Karkouti
Department of Anesthesia and Pain Medicine, University of Toronto
Abstract Background Persistent pain is a common yet debilitating complication after breast cancer surgery. 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. Methods 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 lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/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, 1–3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. Discussion 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. Trial registration This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
