Clinical trial NCT04874038: Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Official title: Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Post-mastectomy Pain Syndrome
Breast Cancer
Pain, Postoperative
Pain, Chronic
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-05-05
Enrollment: 1602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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)

Primary outcomes:
measure: Development of persistent pain 3-months after breast cancer surgery
timeFrame: 3- months
Secondary outcomes:
measure: Pain intensities
timeFrame: 3 and 12 months
measure: Opioid consumption
timeFrame: 3 and 12 months
measure: Moderate-to-severe persistent pain
timeFrame: 3 and 12 months
measure: Persistent neuropathic pain
timeFrame: 3 and 12 months
measure: Sensory and affective qualities of pain
timeFrame: 3 and 12 months
measure: Emotional functioning
timeFrame: 3 and 12 months
measure: Physical functioning
timeFrame: 3 and 12 months
measure: Health-related quality of life quality of life
timeFrame: 3 and 12 months
measure: Cancer Recurrence
timeFrame: 3 and 12 months
measure: Adverse events
timeFrame: 3 and 12 months
measure: Cost Effectiveness
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Sturgeon Community Hospital
state: Alberta
city: St. John's
country: Canada
facility: Eastern Health- Health Sciences Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex
Study officials:
affiliation: University Health Network, Toronto
name: James Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: PJ Devereaux, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kingston Health Sciences Centre
name: Ian Gilron, MD
role: PRINCIPAL_INVESTIGATOR
References: