Once Daily Gabapentin in the Treatment of Post Amputation Pain
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain|
- Change in Pain Numeric Rating Scale at rest [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
- Change in Pain numeric rating scale at movement. [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
- Modified brief pain inventory (short form) [ Time Frame: Visit 1, and visit 5 ] [ Designated as safety issue: No ]Visit 1, baseline; visit 5, eight weeks after visit 1.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Efficacy of Gralise
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776671
|Contact: Nick N Knezevic, M.D. Ph.D.||firstname.lastname@example.org|
|United States, Illinois|
|Chicago Anesthesia Pain Specialists||Recruiting|
|Chicago, Illinois, United States, 60639|
|Contact: Nick N Knezevic, M.D. Ph.D. 773-296-7927 email@example.com|
|Principal Investigator: Kenneth D Candido, MD|
|Principal Investigator:||Kenneth D Candido, M.D.||Chicago Anesthesia Pain Specialists|