Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
Stopped: Trial was stopped due to difficult enrolment
France74 participantsStarted 2010-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female subjects with \>= 18 years of age
* Intact skin in the area of topical treatment
* Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
* Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).
Exclusion Criteria:
* Contraindications to lidocaine 5% medicated plaster, or paracetamol
* Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
* Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
* Pregnant or breastfeeding women
* Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.
* Severe renal, hepatic or heart disorder.
* Surgery in the past 3 months before screening.
* Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
* Pending litigation due to chronic pain or disability.
* Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in th…
What they're measuring
1
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain