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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01540877
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012

February 23, 2012
February 28, 2012
April 2011
September 2011   (final data collection date for primary outcome measure)
grade of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540877 on ClinicalTrials.gov Archive Site
area of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Ipsi- and Contralateral Hypoesthesia
  • Procedure: Application of capsaicin 0.6%
    topical application of 0.6% capsaicin on the volar forearm
  • Procedure: Application of local anesthetics (EMLA plaster)
    topical application of EMLA on the volar forearm
  • Procedure: Application of 1 capsaicin 0.6% and 2. EMLA
    topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
  • Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
    topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
  • Experimental: Capsaicin application
    application of 0.6%
    Intervention: Procedure: Application of capsaicin 0.6%
  • Experimental: Local anesthetics application
    application of EMLA
    Intervention: Procedure: Application of local anesthetics (EMLA plaster)
  • Experimental: Combined application of 1. capsaicin 2. local anesthetics
    application of 1. capsaicin 0.6% and 2. EMLA
    Intervention: Procedure: Application of 1 capsaicin 0.6% and 2. EMLA
  • Experimental: Combined application of 1. local anesthetics and 2. capsaicin
    application of 1. EMLA and 2. capsaicin 0.6%
    Intervention: Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01540877
HypCap
No
Christoph Maier, Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Not Provided
Ruhr University of Bochum
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP