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...
Date First Received: July 18, 2005
Last Updated: September 25, 2008
Verified by: University of Washington, September 2008
Clinical Trial Phase: Phase 4 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Official Title: “Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: valdecoxib
Outcome Measures for this Clinical Trial
Primary Measures
- Cerebrospinal fluid (CSF) valdecoxib concentration
Secondary Measures
- Plasma valdecoxib concentration
- CSF/plasma valdecoxib concentration ratio
- CSF and plasma cytokine concentrations
- Postoperative opioid consumption
- Pain visual analogue scale (VAS) scores
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients undergoing surgery requiring lumbar drain placement
Exclusion Criteria:
- Contraindication to COX-2 inhibitor (renal or hepatic insufficiency)
- Known adverse reaction to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Use of NSAID or COX-2 within 7 days prior to surgery
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Washington
Overall Clinical Trial Officials and Contacts
Evan Kharasch, MD PhD Principal Investigator Washington University School of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00122096
Study ID Number: EDK001
ClinicalTrials.gov Identifier: NCT00122096
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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