Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Intraoperative intravenous lidocaine/placebo infusion |
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).
Other Names:
|
| Placebo Comparator: Control Intraoperative intravenous lidocaine/placebo infusion |
Drug: 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:
|
Outcome Measures
Primary Outcome Measures
- Development of persistent pain 3-months after breast cancer surgery [3- months]
Persistent pain at 3-months
Secondary Outcome Measures
- Pain intensities [3 and 12 months]
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
- 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)
- Physical functioning [3 and 12 months]
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
- 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
Eligibility Criteria
Criteria
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)
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foothills Medical Centre | Calgary | Alberta | Canada | |
| 2 | Misericordia Community Hospital | Edmonton | Alberta | Canada | |
| 3 | University of Alberta Hospital | Edmonton | Alberta | Canada | |
| 4 | Juravinski Hospital | Hamilton | Ontario | Canada | |
| 5 | The Ottawa Hospital | Ottawa | Ontario | Canada | |
| 6 | Humber River Hospital | Toronto | Ontario | Canada | |
| 7 | Mount Sinai Hospital | Toronto | Ontario | Canada | |
| 8 | St. Michael's Hospital | Toronto | Ontario | Canada | |
| 9 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | |
| 10 | University Health Network | Toronto | Ontario | Canada | |
| 11 | Women's College Hospital | Toronto | Ontario | Canada | |
| 12 | Hôpital Maisonneuve-Rosemont | Montréal | Quebec | Canada |
Sponsors and Collaborators
- University Health Network, Toronto
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: James Khan, MD, University Health Network, Toronto
- Principal Investigator: PJ Devereaux, MD.PhD, Population Health Research Institute
- Principal Investigator: Ian Gilron, MD, Kingston Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-5021