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
  Purpose

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.


Condition Intervention
Ipsi- and Contralateral Hypoesthesia
Procedure: 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%

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • grade of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • area of the ipsi- and contralateral hypoesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: April 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capsaicin application
application of 0.6%
Procedure: Application of capsaicin 0.6%
topical application of 0.6% capsaicin on the volar forearm
Experimental: Local anesthetics application
application of EMLA
Procedure: Application of local anesthetics (EMLA plaster)
topical application of EMLA on the volar forearm
Experimental: Combined application of 1. capsaicin 2. local anesthetics
application of 1. capsaicin 0.6% and 2. EMLA
Procedure: Application of 1 capsaicin 0.6% and 2. EMLA
topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
Experimental: Combined application of 1. local anesthetics and 2. capsaicin
application of 1. EMLA and 2. capsaicin 0.6%
Procedure: Application of 1. EMLA and 2. capsaicin 0.6%
topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01540877

Locations
Germany
Department of Pain Medicine
Bochum, Germany
Sponsors and Collaborators
Ruhr University of Bochum
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr. med., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01540877     History of Changes
Other Study ID Numbers: HypCap
Study First Received: February 23, 2012
Last Updated: February 28, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hypesthesia
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Anesthetics
Anesthetics, Local
Capsaicin
EMLA
Anesthetics, Combined
Antipruritics
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014