Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00122096
First received: July 18, 2005
Last updated: September 25, 2008
Last verified: September 2008

July 18, 2005
September 25, 2008
November 2002
Not Provided
Cerebrospinal fluid (CSF) valdecoxib concentration
CSF valdecoxib concentration
Complete list of historical versions of study NCT00122096 on ClinicalTrials.gov Archive Site
  • Plasma valdecoxib concentration
  • CSF/plasma valdecoxib concentration ratio
  • CSF and plasma cytokine concentrations
  • Postoperative opioid consumption
  • Pain visual analogue scale (VAS) scores
  • Plasma valdecoxib concentration
  • CSF/plasma valdecoxib concentration ratio
  • CSF and plasma cytokine concentrations
  • postoperative opioid consumption
  • pain VAS scores
Not Provided
Not Provided
 
Perioperative Inflammation and Cyclooxygenase 2 (COX-2)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Neurosurgery
  • Pain
Drug: valdecoxib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2006
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00122096
EDK001
Not Provided
Not Provided
University of Washington
Pfizer
Principal Investigator: Evan Kharasch, MD PhD Washington University School of Medicine
University of Washington
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP