Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

Phase 4

Completed

• Conditions: Neurosurgery; Pain

• Registration Number: NCT00122096
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-07-18
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-21
• Study Completion: 2006-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebrospinal fluid (CSF) valdecoxib concentration

Secondary Outcome Measures

Name	Time	Method
Plasma valdecoxib concentration
CSF/plasma valdecoxib concentration ratio
CSF and plasma cytokine concentrations
Postoperative opioid consumption
Pain visual analogue scale (VAS) scores

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States