Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

• Assess the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain [ Time Frame: daily ] [ Designated as safety issue: No ]

  Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.)

  Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).

  
  

• To evaluate the effect of lidocaine 5% medicated plaster on quality of life. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  EuroQol-5 Dimension Scores
  
  
• Neuropathic Pain Symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
  
  
• Safety [ Time Frame: up to 44 days ] [ Designated as safety issue: Yes ]
  Measurement of adverse events including laboratory data
  
  
• Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  
• Subject's Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  
• Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  

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.