Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Post-Amputation Pain.

摘要

The purpose of this research is to determine if FDA approved Valproic Acid, commonly used for migraine headache prophylaxis, will also be effective in the prevention of chronic neuropathic pain. Additionally, this research will define the alterations in DNA methylation and gene expression that occur after injury and the extent that valproic acid, a known modulator of DNA methylation, will prevent the epigenetic effects that lead to the development of chronic post-surgical pain. Because this is a double-blinded, randomized controlled trial, we do not anticipate any major findings until the study is closed and the blinding removed. We are pleased to report that there have been no SAEs attributed to study drug, and that the study drug appears to be well tolerated in a generally older, debilitated population. With enrollment less than anticipated, Dr. Buchheit discussed the addition of Duke as an enrollment site with Patricia Henry PhD, Science Officer. On 02 Oct 14 we received notice of approval for the revised Scope of Work and re-budget request from Lisa Wells Roark, DOD Contract Specialist.