Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373893
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2006-09-07
Brief Title:
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgml 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None