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
  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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122096

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Pfizer
Investigators
Principal Investigator: Evan Kharasch, MD PhD Washington University Early Recognition Center
  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 July 24, 2014