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.
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus 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). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,602
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).
Foothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGSturgeon Community Hospital
Edmonton, Alberta, Canada
Development of persistent pain 3-months after breast cancer surgery
Persistent pain at 3-months
Time frame: 3- months
Pain intensities
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Time frame: 3 and 12 months
Opioid consumption
Morphine-equivalent opioid consumption
Time frame: 3 and 12 months
Moderate-to-severe persistent pain
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Time frame: 3 and 12 months
Persistent neuropathic pain
Measured using the Douleur Neuropathique 4-symptoms interview
Time frame: 3 and 12 months
Sensory and affective qualities of pain
Quality of pain is reported using the Short Form McGill Pain Questionnaire
Time frame: 3 and 12 months
Emotional functioning
Emotional functioning is reported using the Profile of Mood States (POMS)
Time frame: 3 and 12 months
Physical functioning
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Time frame: 3 and 12 months
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Eastern Health- Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
RECRUITINGIWK
Halifax, Nova Scotia, Canada
RECRUITINGJuravinski Hospital
Hamilton, Ontario, Canada
RECRUITINGNorth York General Hospital
North York, Ontario, Canada
RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGThunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
RECRUITINGHumber River Hospital
Toronto, Ontario, Canada
RECRUITINGMount Sinai Hospital
Toronto, Ontario, Canada
RECRUITING...and 7 more locations
Health-related quality of life quality of life
Health-related quality of life will be assessed using EQ-5D-5L
Time frame: 3 and 12 months
Cancer Recurrence
Cancer recurrence will be assessed as a secondary outcome
Time frame: 3 and 12 months
Adverse events
Adverse Events will be monitored as a secondary safety outcome
Time frame: 3 and 12 months
Cost Effectiveness
Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
Time frame: 3 months