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Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

This study has been completed.
Information provided by:
University of Washington Identifier:
First received: July 18, 2005
Last updated: September 25, 2008
Last verified: September 2008
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
Drug: valdecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Cerebrospinal fluid (CSF) valdecoxib concentration

Secondary Outcome Measures:
  • 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
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00122096

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: Evan Kharasch, MD PhD Washington University School of Medicine
  More Information Identifier: NCT00122096     History of Changes
Other Study ID Numbers: EDK001
Study First Received: July 18, 2005
Last Updated: September 25, 2008

Keywords provided by University of Washington:

Additional relevant MeSH terms:
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 26, 2017