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).

Details

Title
Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial
Author
Khan, James S. 1   VIAFID ORCID Logo  ; Gilron, Ian 2 ; Devereaux, P. J. 3 ; Clarke, Hance 4 ; Ayach, Nour 5 ; Tomlinson, George 6 ; Quan, May Lynn 7 ; Ladha, Karim S. 8 ; Choi, Stephen 9 ; Munro, Allana 10 ; Brull, Richard 11 ; Lim, David W. 12 ; Avramescu, Sinziana 13 ; Richebé, Philippe 14 ; Hodgson, Nicole 15 ; Paul, James 16 ; McIsaac, Daniel I. 17 ; Derzi, Simone 18 ; Zbitnew, Geoff L. 19 ; Easson, Alexandra M. 20 ; Siddiqui, Naveed T. 1 ; Miles, Sarah J. 21 ; Karkouti, Keyvan 22 ; Parvez, Elena; Hong, Nicole J. Look; Wright, Frances C.; Roberts, Amanda; Escallon, Jaime; Ko, Gary; Huang, Alexander; Zasso, Fabricio B.; Leong, Wey L.; Covelli, Andrea M.; Meng, Howard; Sjaus, Ana; Kerelska, Tina; Uppal, Vishal; Gleicher, Yehoshua; O’Neill, Anne; Wang, Li; Sellers, Daniel; Chuquer, Maria B. C.; Hawboldt, Geoffrey S.; Hofer, Stefan O. P.; Shanthanna, Harsha; Helyer, Lucy K.; Ansari, Bilal M.; Ladak, Salima S. J.; Oyberman, Inna; Cordeiro, Erin; Moreno, Carlos A. Ibarra; Dana, Elad; Busse, Jason W.; Buckley, D Norman; Haykal, Siba; McCluskey, Stuart A.; McKeen, Dolores; Wiegelmann, Julian; Warden, Geoffrey; Sparrow, Kathryn A.; Singh, Mandeep; Bosma, Rachael; Flamer, David; Mah, Richard L.; Diliane, Derek; Bouchard-Fortier, Antoine; Laws, Alison; Drohan, Ashley

1  Mount Sinai Hospital, University of Toronto, Department of Anesthesiology & Pain Medicine, Toronto, Canada (GRID:grid.416166.2) (ISNI:0000 0004 0473 9881) 
2  Queen’s University and Kingston Health Sciences Centre, Departments of Anesthesiology & Perioperative Medicine, and Biomedical & Molecular Sciences, Centre for Neuroscience Studies, and School of Policy Studies, Kingston, Canada (GRID:grid.410356.5) (ISNI:0000 0004 1936 8331) 
3  Population Health Research Institute, McMaster University, Hamilton Health Sciences Corporation, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227) 
4  University of Toronto, Department of Anesthesiology and Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938); Toronto General Hospital, Transitional Pain Service, Toronto, Canada (GRID:grid.417184.f) (ISNI:0000 0001 0661 1177) 
5  University of Toronto, Department of Anesthesiology & Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
6  University Health Network and Mount Sinai Hospital, Department of Medicine, Toronto, Canada (GRID:grid.416166.2) (ISNI:0000 0004 0473 9881); University of Toronto, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
7  University of Calgary, Department of Surgery/Oncology, Calgary, Canada (GRID:grid.22072.35) (ISNI:0000 0004 1936 7697) 
8  University of Toronto, Department of Anesthesiology and Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938); Department of Anesthesia at St. Michael’s Hospital, Toronto, Canada (GRID:grid.415502.7) 
9  University of Toronto, Department of Anesthesiology and Pain Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
10  Dalhousie University, Department of Anesthesia, Pain Management, and Perioperative Medicine, Halifax, Canada (GRID:grid.55602.34) (ISNI:0000 0004 1936 8200) 
11  Women’s College Hospital, University of Toronto, Department of Anesthesiology and Pain Medicine, Toronto, Canada (GRID:grid.417199.3) (ISNI:0000 0004 0474 0188) 
12  Women’s College Research Institute & Department Surgery, Women’s College Hospital, Toronto, Canada (GRID:grid.417199.3) (ISNI:0000 0004 0474 0188) 
13  Humber River Hospital, University of Toronto, Department of Anesthesiology and Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
14  Maisonneuve-Rosemont Hospital, CIUSSS de L’Est de L’Ile de Montreal (CEMTL), University of Montreal, Department of Anesthesiology and Pain Medicine, Montreal, Canada (GRID:grid.14848.31) (ISNI:0000 0001 2292 3357) 
15  McMaster University, Department of Surgery, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227) 
16  McMaster University, Department of Anesthesia, Hamilton, Canada (GRID:grid.25073.33) (ISNI:0000 0004 1936 8227) 
17  The Ottawa Hospital, University of Ottawa, Departments of Anesthesiology & Pain Medicine and School of Epidemiology & Public Health, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000 0001 2182 2255) 
18  University of Alberta, Department of Anesthesiology & Pain Medicine, Edmonton, Canada (GRID:grid.17089.37) 
19  Memorial University, Department of Anesthesiology, St. John’s, Canada (GRID:grid.25055.37) (ISNI:0000 0000 9130 6822) 
20  Mount Sinai Hospital and Princess Margaret Cancer Centre, University of Toronto, Department of Surgery and Institute of Health, Policy, Management and Evaluation (HPME), Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
21  University of Toronto, Department of Anesthesia and Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938) 
22  University of Toronto, Department of Anesthesia and Pain Medicine, Toronto, Canada (GRID:grid.17063.33) (ISNI:0000 0001 2157 2938); University Health Network, Sinai Health System, and Women’s College Hospital, Department of Anesthesia and Pain Management, Toronto, Canada (GRID:grid.17063.33) 
Pages
337
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08151-4
ProQuest document ID
3057545504
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.