NCT00373893

Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Pain
• Hyperalgesia

Interventions

Type	Name	Description
DRUG	Lidoderm Patch

Timeline

• Start date: 2005-12-01
• Completion: 2006-02-01
• First posted: 2006-09-08
• Last updated: 2006-09-08

Locations

1 site across 1 country: United States