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Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients (DepoDur)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335517
First Posted: June 12, 2006
Last Update Posted: December 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
Edward Puzas, University of Rochester
  Purpose
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.

Condition Intervention
Lumbar Spine Surgery Drug: DepoDur

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Further study details as provided by Edward Puzas, University of Rochester:

Primary Outcome Measures:
  • Number of Patients Enrolled and Recieving Injection [ Time Frame: 0-48 hours postoperatively ]

Enrollment: 98
Study Start Date: June 2006
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10mg Depodur Drug: DepoDur
An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDur will be injected.
Experimental: 15mg DepoDur Drug: DepoDur
An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDur will be injected.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335517


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
EKR Therapeutics, Inc
Investigators
Principal Investigator: Rechtine Glenn, MD University of Rochester
  More Information

Responsible Party: Edward Puzas, Doctor, University of Rochester
ClinicalTrials.gov Identifier: NCT00335517     History of Changes
Other Study ID Numbers: 11678
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: February 16, 2012
Results First Posted: January 9, 2013
Last Update Posted: December 19, 2014
Last Verified: December 2012

Keywords provided by Edward Puzas, University of Rochester:
Lumbar surgery
Surgery L3-S1
DepoDur
Post-operative pain
Pain control
Pain relief