Perioperative Inflammation and Cyclooxygenase 2 (COX-2)
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...
Brief Summary
Official Title: “Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization”
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: University of Washington Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00122096
