Valproic Acid for the Prevention of Post-Amputation Pain
Completed · Phase 2
Conditions studied: Pain, Phantom, Pain, Neuropathic
In brief
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.
Key facts
- Study ID
- NCT01928849
- Run by
- Duke University
- People needed
- 128
- Starts
- 2013-12-01
- Expected to finish
- 2017-09-26
- Last updated by the study team
- 2018-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female active duty military personnel or veterans, age 18 years and older.
- Patient is scheduled to undergo amputation, stump revision, or surgery for a limb injury with neurologic damage.
- Patient able to provide written informed consent prior to any study procedures.
You may not qualify if…
- Severe Traumatic Brain Injury (Diagnosis of traumatic brain injury resulting in documented, permanent or prolonged cognitive deficits that would preclude participation in the study)
- Significant cognitive deficits or dementia of any cause as noted in Computerized Patient Record System(CPRS).
- Patient has a designated Legally Authorized Representative
- Substantial hearing loss without alternative means of communication.
- Patient has documented spinal cord injury with permanent or persistent deficits
- Patient is under age 18 or a legal Minor
- Current pregnancy or lactation
- Cirrhosis with evidence of decompensation: coagulopathy International Normalized Ratio (INR) >1.3, thrombocytopenia with platelets <100,000, ascites or hepatic encephalopathy
- Therapy with valproic acid or other valproates, coumadin, chlorpromazine and olanzapine at the time of surgery and study drug administration
- Current diagnosis of seizure disorder requiring anti-epileptic medication
- Current therapy with tricyclic antidepressants (eg: amitriptyline, nortriptyline, imipramine, desipramine) at doses greater than 50mg/day
- Currently taking zidovudine
- Current diagnosis of malaria requiring anti-malaria medication (such as mefloquine and chloroquine)
- Currently taking monoamine oxide inhibitors (MAOI)
- Allergy to valproates or valproic acid
- Contraindication to, or refusal of, regional anesthesia catheter
- BMI > 50
Where it is running
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Duham VA Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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