Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122096
Status:
COMPLETED
Last Update Posted:
2008-09-26
First Post:
2005-07-18
Brief Title:
Perioperative Inflammation and Cyclooxygenase 2 COX-2
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Preoperative Valdecoxib CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization
Status:
COMPLETED
Status Verified Date:
2008-09
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:
Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor
Detailed Description:
Surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response COX-2 inhibitors are often used for treating pain This is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes The hypothesis is that valdecoxib will reach therapeutic concentrations in CSF and will decrease plasma and CSF concentrations of inflammatory mediators Subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery Serial blood and CSF samples will be obtained Valdecoxib and cytokine concentrations will be measured
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