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Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

NCT ID: NCT00122096

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Neurosurgery Pain

Keywords

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neurosurgery COX-2 inflammation pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valdecoxib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Principal Investigators

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Evan Kharasch, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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EDK001

Identifier Type: -

Identifier Source: org_study_id