Pain Clinical Trial
Official title:
Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Some patients who undergo different types of surgery develop distressing and long-lasting
pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus
which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch).
Patients describe symptoms of burning or electrical type sensation. In some cases this type
of chronic pain can still be present after 3 months or more following surgery.This clinical
trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in
comparison to placebo plaster in patients.
This trial is a randomized, double-blind (neither investigator nor patient will know which
treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate
topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include
a screening phase and a treatment phase, during which subjects will be treated with either 5%
lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily
basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI)
will be collected via the numeric rating scale and averaged. Safety evaluations include
monitoring of adverse events, physical examinations, and clinical laboratory tests.
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