CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
DepoDurdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00335517
NCT00335517N/ACompleted
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Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

University of Rochester·interventional·Posted Jun 12, 2006·Updated Dec 19, 2014

In Brief

A clinical study evaluating DepoDur for Lumbar Spine Surgery. Completed, enrolled 98 participants across 1 site.

Detailed Summary

The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spine Surgery
CountriesUnited States
CollaboratorsEKR Therapeutics, Inc

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2006
Enrollment StartJun 1, 2006
Primary CompletionSep 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.1 years ago

Interventions

DepoDurdrug

An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDur will be injected.