Is there a correlation between the pain relief and the A-delta- and C-fiber function after topical application of lidocaine (5%) in patients with peripheral neuropathic pain?

BG University Hospital Bergmannsheil GmbH0 个研究点目标入组 30 人开始时间: 2011年7月25日最近更新: 2012年3月19日

试验速览

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•Included will be patients 18 years and older either genera with:
•-Proven Diagnosis of painful peripheral neuropathy for at least 3 months as diagnosed as:
•1.Peripheral nerve lesion (i.e. pain within or adjacent to the area of nerve trauma or corresponding innervation territory or dermatome)
•2.Postherpetic neuralgia (Subjects with pain following herpes zoster with > 3 months after healing of herpes zoster skin rash).
•- At least moderate pain intensity under the current treatment.
•- Unchanged and stable pain medication within the last 4 weeks.
•- The patients have to display some remaining sensory function at the baseline QST.
•- Intact skin in the area of lidocaine medicated plaster application.
•- Females with childbearing potential must be using adequate contraception.
•- Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-HCG) pregnancy test.
•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

•Excluded will be patients with:
•- History of current alcohol or drug abuse.
•- Any scheduled surgery of painful procedure during the course of the trial.
•- Presence of a disease that affects the subject’s compliance.
•- Use of any topical anaesthetics in the area of pain within the last 6 months.
•- Use of capsaicin (low or high-dose) in the area of pain within the last 6 months.
•- Use of TENS within the area of pain in the last 4 weeks.
•- Subjects who had nerve ablation by block or neurosurgical intervention for pain treatment at the affected area.
•- Evidence or another cause of pain within the area of pain or another severe pain condition that may interfere with the trial aims or procedures.
•- Severe loss of sensory function
•- Contraindications or hypersensitivity to local anaesthetics of amide type or to any of the exipients.
•- Intake of class I antiarrhythmic drugs (e.g. tocainide, mexilitine).
•- Use of systemically applied local anaesthetics within the last 4 weeks
•- Active herpes zoster lesion, dermatitis or skin lesions of any origin within the area of pain.
•- Clinically relevant cardiac insufficiency (NYHA Class III to IV)
•- Clinical relevant severe impairment of the kidney or liver function

发起方

BG University Hospital Bergmannsheil GmbH