drugset / Trial / NCT01384877

Subcutaneous Lidocaine For Cancer-Related Pain

NCT01384877

RandomizedCrossoverTriple-blindSupportive care

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.

Timeline

Start
2011-12
Primary completion
2017-12
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 10 mg/kg Subcutaneous

Indications

No indication recorded.