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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874038
• Other study ID #: 21-5021
• Status: Recruiting
• Phase: Phase 3
• Start date: September 22, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: James Khan
• Phone: 416-340-4800
• Email: James.Khan[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1602
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain, Chronic
• Pain, Postoperative
• Post-mastectomy Pain Syndrome

Intervention

Drug:
• 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).
• 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).

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Sturgeon Community Hospital	Edmonton	Alberta
Canada	IWK	Halifax	Nova Scotia
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Eastern Health- Health Sciences Centre	St. John's	Newfoundland and Labrador
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

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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