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

摘要

The purpose of this research is to determine if an FDA approved medication (valproic acid), commonly used for migraine headache prophylaxis, will also be effective in the prevention of chronic neuropathic pain following amputation, stump revision or surgery for mangled limb. 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. The scope of this research involves injured military service members and veterans undergoing amputation, stump revision surgery or surgery for mangled limbs with neurologic damage. Progress to date includes protocol and SOP development, database creation in REDCap (Research Electronic Data Capture), IRB submission and approval at the Durham VAMC and Duke University, as well as submission and secondary approval from HRPO. Additionally, the protocol has been uploaded and approved by Clinicaltrials.gov. CRADA submission has been performed to the VAMC. Study enrollment will begin at the Durham VAMC as soon as CRADA approval is obtained.