Lidocaine for Neuropathic Cancer Pain (LiCPain): A Pilot Randomized Controlled Trial.

Area of Science:

• Palliative Care
• Pain Management
• Clinical Pharmacology

Background:

• Continuous subcutaneous infusion of lidocaine is used for neuropathic cancer pain.
• A need exists for robust clinical trials to confirm efficacy and safety.

Purpose of the Study:

• To assess the feasibility of a phase III randomized controlled trial (RCT) for continuous subcutaneous infusion of lidocaine versus placebo.
• To evaluate the potential for recruiting and retaining patients with neuropathic cancer pain in a multisite trial.

Main Methods:

• Adult patients with neuropathic cancer pain were randomized to receive titrated continuous subcutaneous infusion of lidocaine or placebo over 72 hours.
• Dose titration ranged from 1 to 2 mg/kg/h, capped at 120 mg/hour.
• Feasibility was assessed by recruitment rates, medication completion, and adverse events.

Main Results:

• Seventeen participants were recruited over 54 months, with a 93% completion rate for study medication and procedures.
• Eighty-eight percent of participants completed the full 72 hours of study medication.
• Adverse events were infrequent and mild/moderate; no significant difference in pain reduction was observed between groups.

Conclusions:

• This pilot study demonstrates the feasibility of a phase III RCT for continuous subcutaneous infusion of lidocaine in neuropathic cancer pain.
• Recruitment strategies require refinement, and higher lidocaine doses warrant cautious investigation.
• Findings inform clinical practice and future research on subcutaneous lidocaine infusion.