Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Completed · Not applicable

Conditions studied: Lumbar Spine Surgery

In brief

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.

Key facts

Study ID

NCT00335517

Run by

University of Rochester

People needed

98

Starts

2006-06-01

Expected to finish

2010-11-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All mentally competent patients over the age of 18 undergoing lumbar surgery at L3-S1 who would be expected to be hospitalized for greater than 48 hours would be eligible for this study.

You may not qualify if…

• Patients less than 18 years old, those not able to give consent, prisoners, patients with allergies to narcotic analgesics, and pregnant women will be excluded.
• Women who are pregnant or are not practicing medically acceptable contraception (a pregnancy test is used pre-operatively as part of standard of care).
• Patients who experience complications during the surgery (e.g., major hemorrhage, dural puncture) will not receive the study drug.

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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