Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122096

Enrollment

Registered

2005-07-21

Start date

2002-11-30

Completion date

2006-01-31

Last updated

2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosurgery, Pain

Keywords

neurosurgery, COX-2, inflammation, pain

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.

Interventions

DRUGvaldecoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cerebrospinal fluid (CSF) valdecoxib concentration	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026