Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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- STATUS
- Recruiting
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- End date
- Dec 1, 2024
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- participants needed
- 1150
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- sponsor
- University Health Network, Toronto
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 1,150 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
Details
| Condition | Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic |
|---|---|
| Treatment | Placebo, Lidocaine 20mg/ml |
| Clinical Study Identifier | NCT04874038 |
| Sponsor | University Health Network, Toronto |
| Last Modified on | 12 March 2022 |
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