Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

Inclusion Criteria:

• Male or female subjects aged 18 years or older.

• Subjects suffering from moderate to severe localized chronic PoNP (post operativeneuropathic pain) pain following surgery (e.g., thoracotomy, total/partial kneereplacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose veinstripping).

• Localized PoNP present for at least 3 months.

• Size of the affected painful skin area is not larger than the size of 3 plasters.

• Intact skin besides the scar of surgery in the area of plasters application

• Baseline average pain intensity of 4 or greater on the 11 point pain intensity NumericRating Scale.

Exclusion Criteria:

• Participation in another trial (with medicine or a device under investigation) inparallel or less than 30 days prior to enrollment in this trial.

• Previous enrollment in this trial.

• History of dependency or active drug abuse (alcohol, medication) during the 1 yearprior to enrollment.

• Evidence or history (during the 3 years prior to enrollment) of neurotic personalityor psychiatric illness that in the investigator's opinion may affect efficacy orsafety assessments or may compromise the subjects safety during trial participation.

• Pregnant or breastfeeding women or women of childbearing potential who are sexuallyactive without satisfactory contraception.

• Any surgery performed in the 3 months prior to enrollment, which may affect efficacyor safety assessment.

• Any surgery scheduled or expected during the trial.

• Clinically significant disease (e.g., acquired immunodeficiency syndrome) or conditionthat may affect efficacy or safety assessments, or any other reason which, ininvestigator's opinion, may preclude the subject's participation in the trial.

• History of malignancy (with the exception of neoplasia related to the trialindication) within 2 years prior to enrollment.

• Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasiaor metastases.

• Pending litigation due to chronic pain or disability.

• Total anesthesia in the cutaneous area neurologically related to the location of thesurgical intervention.

• Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anestheticsof the amide type.

• Any former use of topical lidocaine in the area of localized chronic PoNP.

• Severe renal, hepatic or heart disorder.