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
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