Valproic Acid for the Prevention of Post-Amputation Pain
Status:
Completed
Trial end date:
2017-09-26
Target enrollment:
Participant gender:
Summary
The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the
prevention of chronic neuropathic and post-amputation pain, as well as to further define the
underlying inflammatory and epigenetic mechanisms that lead to the development of such
chronic pain.
HYPOTHESES AND QUESTIONS
Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in
surgical limb-injury patients will decrease the incidence of chronic nerve injury and
post-amputation pain.
Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial,
investigators will determine if oral VPA added to regional anesthesia and standard
perioperative management will reduce the incidence of nerve injury and post-amputation pain
when compared with regional anesthesia alone.
Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic mechanisms
(differential DNA methylation) in genes involved in nociception.
Goal 2: Investigators will analyze the DNA methylation patterns of patients with different
types of neuropathic and post-amputation pain and determine if they are altered by VPA.