At a glance
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A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
In Brief
A Phase 3 clinical trial evaluating Lidocaine and Placebo (D5W) for Cancer-related Pain. Completed, enrolled 33 participants across 2 sites.
Detailed Summary
This study's primary objective is to test the hypothesis that a single infusion of subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement. We will use a composite endpoint of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or placebo, followed at least 1 week later by the alternate agent.
Study Details
Timeline
Interventions
10mg/kg by subcutaneous infusion over 5.5 hours
Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)