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

Phase 3

Recruiting

• Conditions: Breast Cancer; Pain, Chronic; Post-mastectomy Pain Syndrome; Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Lidocaine 20mg/ml

• Registration Number: NCT04874038
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Study Start: 2021-09-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1602

Inclusion Criteria

1. Age ≥18 years old
2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

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Exclusion Criteria

1. Previous breast surgery within 6 months of index surgery
2. Undergoing any autologous flap procedure during index surgery
3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
4. Documented hypersensitivity or allergy to lidocaine
5. 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)
6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
7. Known cirrhotic liver disease
8. Pregnant
9. 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Intraoperative intravenous lidocaine/placebo infusion
Intervention	Lidocaine 20mg/ml	Intraoperative intravenous lidocaine/placebo infusion

Primary Outcome Measures

Name	Time	Method
Development of persistent pain 3-months after breast cancer surgery	3- months	Persistent pain at 3-months

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	3 and 12 months	Morphine-equivalent opioid consumption
Pain intensities	3 and 12 months	Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Emotional functioning	3 and 12 months	Emotional functioning is reported using the Profile of Mood States (POMS)
Adverse events	3 and 12 months	Adverse Events will be monitored as a secondary safety outcome
Cost Effectiveness	3 months	Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
Sensory and affective qualities of pain	3 and 12 months	Quality of pain is reported using the Short Form McGill Pain Questionnaire
Persistent neuropathic pain	3 and 12 months	Measured using the Douleur Neuropathique 4-symptoms interview
Physical functioning	3 and 12 months	Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Moderate-to-severe persistent pain	3 and 12 months	Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Health-related quality of life quality of life	3 and 12 months	Health-related quality of life will be assessed using EQ-5D-5L
Cancer Recurrence	3 and 12 months	Cancer recurrence will be assessed as a secondary outcome

Trial Locations

Locations (16)

Obafemi Awolowo University Teaching Hospitals Complex; 🇳🇬 Ile-Ife, Nigeria

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; 🇨🇦 Montréal, Quebec, Canada