Pain Clinical Trial
Official title:
Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation
from peripheral vascular disease, peripheral neuropathic disease, neoplasm or traumatic
events. Even though the cause of PLP remains unclear and the large number of treatments has
been suggested, there is no single treatment regimen proving long lasting pain relief for
PLP. However Gabapentin is widely used and have been well suggested recently for the
treatment of neuropathic pain.
The purpose of this study is to evaluate the accuracy and efficacy achieved in using of
extended release Gabapentin to offer effective pain relief, improvement of sleep function,
and decrease problematic side effects related to the peaks and valleys of the drug's short
cycle in patients with PLP. Gabapentin has been clearly demonstrated to be effective in
neuropathic pain and epilepsy, but as a treatment option for post amputation pain, it has not
been tested.
Approximately, 20 patients will be enrolled in the study, after a titration of two weeks a
changing in pain intensity and quality of life will be obtained at subsequent visits. We are
expected that the accuracy will be of benefit in reducing the incidence of chronic
post-amputation pain and improving clinical outcomes postoperatively.
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