Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00373893
First received: September 7, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted

September 7, 2006
September 7, 2006
December 2005
Not Provided
  • Neurosensory testing
  • Four neurosensory tests: warm and cold sensation,warm/cold pain/touch/mechanical pain.
  • Warm and cold sensation measured w/a Thermal Sensory
  • Touch will be measured using von Frey hairs. Calibrated von Frey hairs are filaments of varying size. The filament are selected at random and 3 successive stimuli are applied for 1.5 second at 5 second intervals per filament
  • Mechanical pain will be measured using von Frey hairs. Endpoint will be pain.
Same as current
No Changes Posted
  • Allodynia and Hyperalgesia
  • At the completion of the stimulation, areas of cutaneous allodynia and hyperalgesia will be mapped. The region of hyperalgesia will be established with a 5.18 von Frey hair, and the area of allodynia with a foam brush gently stroked on the skin.
Same as current
Not Provided
Not Provided
 
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin

A randomized, double-blinded, placebo controlled methodology will be conducted. At the session subjects will be exposed to placebo patch and lidocaine patch. Prior to study drug administration, a baseline neurosensory test on the volar aspect of both forearms will be performed and baseline vital signs will be measured. A placebo patch and a lidocaine patch will then be applied to the volar aspect of each forearm. The arms will be randomized to which arm receives placebo and which one receives the lidocaine patch. After four hours of application the right forearm patch will be removed the neurosensory testing will be repeated on the right forearm. After completing the testing, capsaicin (10µl, 10 mg/ml) will be injected intradermally on the volar aspect of the right forearm. Elicited and spontaneous pain scores, blood pressure, heart rate, and respiratory rate will be measured at the time of injection and every 2.5 minutes for 10 minutes. A McGill Pain Questionnaire will be administered at the time of capsaicin injection only. Ten minutes after the capsaicin injection, the hyperalgesic area will be established to von Frey hair, stroking, and heat; the flare response will be outlined; and neurosensory testing will performed halfway between the edge of this defined area and the capsaicin injection site. At the completion of the testing on the right forearm, the left forearm patch will be removed and the procedures described for the right forearm will be repeated for the left forearm.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pain
  • Hyperalgesia
Drug: Lidoderm Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2006
Not Provided

Inclusion Criteria:

  • Age 18 and above

Exclusion Criteria:

  • Pregnancy.
  • Allergy to lidocaine
  • Current painful condition
  • Current use of analgesics for the treatment of pain
  • Lack of ability to understand the experimental protocol and to adequately communicate in English. The neurosensory testing we plan to perform requires the complete cooperation and understanding of the subject. It would be impossible to perform these studies on patients who do not adequately communicate in English.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373893
051252
Not Provided
Not Provided
University of California, San Diego
Not Provided
Principal Investigator: Mark S. Wallace, MD University of California, San Diego
University of California, San Diego
October 2005

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