Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00122096
• Collaborator: Pfizer (Industry)
• Enrollment: 30
• Location: 1
• Duration (Months): 38
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neurosurgery; Pain	Drug: valdecoxib	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization
• Study Start Date: Nov 1, 2002
• Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. Cerebrospinal fluid (CSF) valdecoxib concentration []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington
• Pfizer

Investigators

• Principal Investigator: Evan Kharasch, MD PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00122096
• Other Study ID Numbers: EDK001
• First Posted: Jul 21, 2005
• Last Update Posted: Sep 26, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: neurosurgery; COX-2; inflammation; pain
• Additional relevant MeSH terms: Inflammation; Valdecoxib

Study Results

No Results Posted as of Sep 26, 2008