Perioperative Inflammation and Cyclooxygenase 2 (COX-2)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurosurgery Pain |
Drug: valdecoxib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization |
- Cerebrospinal fluid (CSF) valdecoxib concentration
- Plasma valdecoxib concentration
- CSF/plasma valdecoxib concentration ratio
- CSF and plasma cytokine concentrations
- Postoperative opioid consumption
- Pain visual analogue scale (VAS) scores
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Evan Kharasch, MD PhD | Washington University School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00122096 History of Changes |
| Other Study ID Numbers: | EDK001 |
| Study First Received: | July 18, 2005 |
| Last Updated: | September 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
neurosurgery COX-2 inflammation pain |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes Valdecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on October 16, 2012
