An interventional study of Lidocaine and Placebo in Neuropathic Pain, Amputation, Traumatic and Nerve Block, sponsored by Danish Pain Research Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Danish Pain Research Center · Not applicable, Interventional, and Diagnostic
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's enrollment of 12 is below the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Danish Pain Research Center is the lead sponsor of 24 studies on the registry; none are open to participants now.
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Device: Lidocaine
Drug: Placebo
Intervention is a nerve block with Lidocaine 2% with Adrenaline.
Intervention is a "placebo" nerve block with isotonic saline
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain).
Time frame: From 0 minutes until 120 minutes after injection
Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
The patient will be asked about evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). Evoked pain is triggered by a SOMEDIC brush, thermo rolls (20 degrees Celcius and 40 degrees Celcius) and pinprick with a von Frey filament (60 g).
Time frame: From 0 minutes until 120 minutes after injection
Ran from Oct 2017 to primary completion in Feb 2018, 4 months.
Of 246 non-industry interventional studies with no phase under Neuralgia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 4 months is below that.
Counting every sponsor, half of 264 studies reached it within 24 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Danish Pain Research Center