Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
1 other identifier
interventional
1,602
3 countries
17
Brief Summary
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2021
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedNovember 17, 2025
November 1, 2025
4.4 years
April 20, 2021
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Development of persistent pain 3-months after breast cancer surgery
Persistent pain at 3-months
3- months
Secondary Outcomes (11)
Pain intensities
3 and 12 months
Opioid consumption
3 and 12 months
Moderate-to-severe persistent pain
3 and 12 months
Persistent neuropathic pain
3 and 12 months
Sensory and affective qualities of pain
3 and 12 months
- +6 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALIntraoperative intravenous lidocaine/placebo infusion
Control
PLACEBO COMPARATORIntraoperative intravenous lidocaine/placebo infusion
Interventions
Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).
Eligibility Criteria
You may qualify if:
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
You may not qualify if:
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
- Known cirrhotic liver disease
- Pregnant
- Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Foothills Medical Centre
Calgary, Alberta, Canada
Sturgeon Community Hospital
Edmonton, Alberta, Canada
Eastern Health- Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
IWK
Halifax, Nova Scotia, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
North York General Hospital
North York, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
B.P. Koirala Institute of Health Sciences
Dharān, Nepal
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Nigeria
Related Publications (1)
Khan JS, Gilron I, Devereaux PJ, Clarke H, Ayach N, Tomlinson G, Quan ML, Ladha KS, Choi S, Munro A, Brull R, Lim DW, Avramescu S, Richebe P, Hodgson N, Paul J, McIsaac DI, Derzi S, Zbitnew GL, Easson AM, Siddiqui NT, Miles SJ, Karkouti K; PLAN Trial Investigators. Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial. Trials. 2024 May 22;25(1):337. doi: 10.1186/s13063-024-08151-4.
PMID: 38773653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Khan, MD
University Health Network, Toronto
- PRINCIPAL INVESTIGATOR
PJ Devereaux, MD.PhD
Population Health Research Institute
- PRINCIPAL INVESTIGATOR
Ian Gilron, MD
Kingston Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2021
First Posted
May 5, 2021
Study Start
September 22, 2021
Primary Completion
March 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share