N/A N=100 Randomized Treatment

Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Lumbar Spine Surgery

Bottom Line

View on ClinicalTrials.gov: NCT00335517 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcome: Primary: Number of Patients Enrolled and Recieving Injection — 98 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DepoDur (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Enrolled and Recieving Injection	98	—

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.

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.

View full record on ClinicalTrials.gov →

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.