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Completed

NCT Number: NCT01540877

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

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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Key information

Conditions

Ipsi- and Contralateral Hypoesthesia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pain Medicine

Bochum, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application of capsaicin 0.6%

Procedure

topical application of 0.6% capsaicin on the volar forearm

Application of local anesthetics (EMLA plaster)

Procedure

topical application of EMLA on the volar forearm

Application of 1 capsaicin 0.6% and 2. EMLA

Procedure

topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm

Application of 1. EMLA and 2. capsaicin 0.6%

Procedure

topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm

Primary outcomes

  1. grade of the ipsi- and contralateral hypoesthesia

    Time frame: 6 months

Secondary outcomes

  1. area of the ipsi- and contralateral hypoesthesia

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 29, 2012
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.