Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic
Conditions
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
Interventions
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).
DRUGPlacebo
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).
Sponsors
Canadian Institutes of Health Research (CIHR)
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of persistent pain 3-months after breast cancer surgery | 3- months | Persistent pain at 3-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 3 and 12 months | Morphine-equivalent opioid consumption |
| Moderate-to-severe persistent pain | 3 and 12 months | Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours |
| Persistent neuropathic pain | 3 and 12 months | Measured using the Douleur Neuropathique 4-symptoms interview |
| Sensory and affective qualities of pain | 3 and 12 months | Quality of pain is reported using the Short Form McGill Pain Questionnaire |
| Emotional functioning | 3 and 12 months | Emotional functioning is reported using the Profile of Mood States (POMS) |
| Pain intensities | 3 and 12 months | Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement. |
| 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 |
| 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 |
| Physical functioning | 3 and 12 months | Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form. |
Countries
Canada, Nepal, Nigeria
Contacts
Primary ContactJames Khan
Backup ContactNour Ayach
Outcome results
None listed