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

Information source: Ruhr University of Bochum
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ipsi- and Contralateral Hypoesthesia

Intervention: Application of capsaicin 0.6% (Procedure); Application of local anesthetics (EMLA plaster) (Procedure); Application of 1 capsaicin 0.6% and 2. EMLA (Procedure); Application of 1. EMLA and 2. capsaicin 0.6% (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Ruhr University of Bochum

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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: grade of the ipsi- and contralateral hypoesthesia

Secondary outcome: area of the ipsi- and contralateral hypoesthesia

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Department of Pain Medicine, Bochum, Germany
Additional Information

Starting date: April 2011
Last updated: February 28, 2012

Page last updated: August 23, 2015

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