Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

This study has been completed.
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00335517
First received: June 8, 2006
Last updated: December 5, 2012
Last verified: December 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Further study details as provided by University of Rochester:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00335517     History of Changes
Other Study ID Numbers: 11678
Study First Received: June 8, 2006
Results First Received: February 16, 2012
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014