Breast Cancer, Cancer

Phase 3

Interventional Study

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

Sponsor

University Health Network, Toronto

Start Date

22/09/2021

Completion Date

01/01/2024

Sex

ALL

Enrollment

1150

Ages From

18

Healthy Volunteers?

Yes

Contact

James Khan,

Location

Foothills Medical Centre

Trial Details

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.

Official Title

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

Detailed Description

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,150 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

Selection Criteria

Eligibility Inclusion Criteria

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)

Eligibility Exclusion Criteria

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)

ARMS & Interventions

PARTICIPANT GROUP ARMINTERVENTION TREATMENT
Experimental: Intervention Intraoperative intravenous lidocaine/placebo infusionDrug: Lidocaine 20mg/ml 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). Other Names: Lidocaine 2%
Placebo Comparator: Control Intraoperative intravenous lidocaine/placebo infusionDrug: Placebo 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). Other Names: 0.9% sodium chloride solution

Primary Outcome

MeasuresMeasure DescriptionMEASURE TIME FRAME
Development of persistent pain 3-months after breast cancer surgeryPersistent pain at 3-months3- months

Secondary Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Pain intensitiesPain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Opioid consumptionMorphine-equivalent opioid consumption3 and 12 months
Moderate-to-severe persistent painDefined as persistent pain with an NRS pain score of ≥4 at rest 24-hours3 and 12 months
Persistent neuropathic painMeasured using the Douleur Neuropathique 4-symptoms interview3 and 12 months
Sensory and affective qualities of painQuality of pain is reported using the Short Form McGill Pain Questionnaire3 and 12 months
Emotional functioningEmotional functioning is reported using the Profile of Mood States (POMS)3 and 12 months
Physical functioningPhysical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.3 and 12 months
Health-related quality of life quality of lifeHealth-related quality of life will be assessed using EQ-5D-5L3 and 12 months
Cancer RecurrenceCancer recurrence will be assessed as a secondary outcome3 and 12 months
Adverse eventsAdverse Events will be monitored as a secondary safety outcome3 and 12 months

Other Outcome

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