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 IV

Further Study Details: 

Primary Outcomes: Cerebrospinal fluid (CSF) valdecoxib concentration
Secondary Outcomes: Plasma valdecoxib concentration; CSF/plasma valdecoxib concentration ratio; CSF and plasma cytokine concentrations; Postoperative opioid consumption; Pain visual analogue scale (VAS) scores
Expected Total Enrollment:  30

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   -   80 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00122096

Evan Kharasch, MD PhD      206-543-4070    kharasch@u.washington.edu

Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting

Study chairs or principal investigators

Evan Kharasch, MD PhD,  Principal Investigator,  University of Washington   

Study ID Numbers:  EDK001
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122096
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26