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Completed

NCT Number: NCT00122096

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

Primary outcomes

  1. Cerebrospinal fluid (CSF) valdecoxib concentration

Secondary outcomes

  1. Plasma valdecoxib concentration

  2. CSF/plasma valdecoxib concentration ratio

  3. CSF and plasma cytokine concentrations

  4. Postoperative opioid consumption

  5. Pain visual analogue scale (VAS) scores

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Pfizer

Registry information

Official study title

Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization

Important dates

Study start
2002
Study completion
2006
First posted
Jul 21, 2005
Registry last updated
Sep 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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