Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study

Area of Science:

• Oncology
• Pain Management
• Pharmacology

Background:

• Neuropathic cancer pain is often unrelieved by current treatments.
• Existing analgesics may have significant side effects, limited efficacy data, and potential harms.
• Local anesthetic lidocaine, administered via continuous subcutaneous infusion, shows promise for managing this pain.

Purpose of the Study:

• To determine the feasibility of a definitive phase III trial.
• To evaluate the efficacy and safety of continuous subcutaneous lidocaine infusion for neuropathic cancer pain.
• To gather pharmacokinetic, safety, and patient experience data to inform future research.

Main Methods:

• A mixed-methods pilot study incorporating a phase II double-blind, randomized controlled trial.
• Participants received either lidocaine hydrochloride 10% infusion or placebo over 72 hours.
• Includes pharmacokinetic and qualitative substudies on patient and caregiver experiences.

Main Results:

• The pilot study aims to provide crucial safety data.
• It will assess the feasibility of recruitment, randomization, and outcome measures for a larger trial.
• Preliminary data will indicate the potential efficacy and patient acceptability of the intervention.

Conclusions:

• Continuous subcutaneous lidocaine infusion is a promising strategy for neuropathic cancer pain.
• This pilot study is essential for designing a robust phase III trial.
• Further investigation is warranted to establish lidocaine as a safe and effective treatment option.