Status:
COMPLETED
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
EKR Therapeutics, Inc
Conditions:
Lumbar Spine Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Patients will be recruited from the general practices of Drs. Rechtine, Rubery, Molinari, and Zeidman. An epidural catheter will be placed under direct vision at the conclusion of surgery. The cathete...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00335517
Start Date
June 1 2006
End Date
November 1 2010
Last Update
December 19 2014
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642