Overview

Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Status:
Completed

Trial end date:
2010-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Rochester

Collaborator:

EKR Therapeutics, Inc

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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.