A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics

Not Applicable

Completed

• Conditions: Ipsi- and Contralateral Hypoesthesia

• Registration Number: NCT01540877
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Last Update Submitted: 2012-02-28
• Study First Posted: 2012-02-29
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• healthy subject, older than 18 years, provided written informed consent

Exclusion Criteria

• insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
grade of the ipsi- and contralateral hypoesthesia	6 months

Secondary Outcome Measures

Name	Time	Method
area of the ipsi- and contralateral hypoesthesia	6 months

Trial Locations

Locations (1)

Department of Pain Medicine; 🇩🇪 Bochum, Germany