---
title: Perioperative Inflammation and Cyclooxygenase 2 (COX-2)
nct_id: NCT00122096
overall_status: COMPLETED
phase: PHASE4
sponsor: University of Washington
study_type: INTERVENTIONAL
primary_condition: Neurosurgery
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00122096.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00122096"
ct_last_update_post_date: 2008-09-26
last_seen_at: "2026-05-12T06:59:33.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

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

**NCT ID:** [NCT00122096](https://clinicaltrials.gov/study/NCT00122096)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** University of Washington
- **Collaborators:** Pfizer
- **Conditions:** Neurosurgery, Pain
- **Start Date:** 2002-11
- **Completion Date:** 2006-01
- **CT.gov Last Update:** 2008-09-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Interventions

- **valdecoxib** (DRUG)

## Primary Outcomes

- **Cerebrospinal fluid (CSF) valdecoxib concentration**

## Secondary Outcomes

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

## Locations (1)

- University of Washington, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of washington|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00122096.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00122096*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*