Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122096
• Other study ID #: EDK001
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2005
• Last updated: September 25, 2008
• Start date: November 2002
• Est. completion date: January 2006

Study information

• Verified date: September 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurosurgery
• Pain

Intervention

Drug:
• valdecoxib

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrospinal fluid (CSF) valdecoxib concentration
Secondary	Plasma valdecoxib concentration
Secondary	CSF/plasma valdecoxib concentration ratio
Secondary	CSF and plasma cytokine concentrations
Secondary	Postoperative opioid consumption
Secondary	Pain visual analogue scale (VAS) scores