N/A
Completed N=100
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Lumbar Spine Surgery
Source: ClinicalTrials.gov NCT00335517 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Number of Patients Enrolled and Recieving Injection — 98 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Enrolled and Recieving Injection |
98 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00335517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.