Topical lidocaine: Predictors of response in peripheral nerve damage

Conditions: europathic pain due to Peripheral nerve damage
MedDRA version: 12.1Level: HLTClassification code 10011302Term: Peripheral nerve injuries
MedDRA version: 12.1Level: LLTClassification code 10034586Term: Peripheral nerve injury

Registration Number: EUCTR2009-016038-29-DK

Lead Sponsor: Danish Pain Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients with focal neuropathic pain for at least 3 months following a peripheral nerve injury due to trauma or surgery are eligible. The neuropathic pain should be within a skin area with positive or negative sensory signs corresponding to the territory of the injured peripheral nerve/nerves
2. Patients aged 18 years or above with a pain intensity of at least 4 on a 0-10 point NRS scale at the first visit (screening)
3. Intact skin i the area where the plaster is to be applied.
4. Written informed consent has been obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Other diseases: Diabetes, symptomatic cardiovascular, liver or kidney diseases, neurological diseases other than peripheral nerve injury.
2. Other pains that may make it difficult to discriminate these pains from the pain originating from the nerve injury.
3. Allergy to lidocaine or some of the substances in the medicine.
4. Skin diseases in the area where the patches are to be applied.
5. Pregnant or lactating women. Fertile women must be in sufficient contraception and have a negative pregnancy test.
6. Persons who cannot cope with the study or are unable to conduct the study because of lack of understanding of danish, mental illness, abuse of alcohol or drugs.
7. Patients who are in treatment with class I antiarrhythmic agents.
8. Patients who were in treatment with Na2+ -channel blockers in the recent month or in treatment with capsaicin in the recent 3 months.
9. Patients in treatment with TENS or acupuncture.