Subcutaneous Lidocaine For Cancer-Related Pain

Official Title

A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain

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. Subjects will receive either lidocaine or placebo, followed at least 3 weeks later by the alternate agent.

Trial Description

Primary Outcome:

  • Reduction in worst pain intensity or reduction in 24hr opioid dose of at least 30% without worsening of pain scores
Secondary Outcome:
  • Incidence of adverse events.
  • Quality of Life
  • Duration of response to lidocaine infusion.
Ten mg/kg of lidocaine will be infused subcutaneously via a Baxter infusor over a 5.5 hour period in ambulatory adult cancer patients with aworst pain score of at least 4 out of 10 despite therapy with at least one opioid plus appropriate oral adjuvant analgesic(s). 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. The secondary objectives are 1) to determine whether any significant toxicities occur as a result of the infusion. For this study significant toxicity is considered as any adverse event which either leads to the infusion being terminated, or which leads to medical intervention, such as prescribing of another medication or equivalent treatment, 2) to determine the effect of Lidocaine infusion on QOL parameters as measured by the Patient Outcome Scale (POS) Questionnaire and 3) to determine the duration of response to lidocaine infusion.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society