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Valproic Acid for the Prevention of Post-Amputation Pain

CompletedPhase 2NCT01928849
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Post-Amputation Pain
Conditions
Interventions
  • Drug: Valproic Acid
  • Other: Cherry Syrup
Sponsor
Duke University
Collaborators
United States Department of Defense
Start date
2013-12
Primary completion
2017-09-26
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01928849