Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

This study is currently recruiting participants.

Verified by University of Rochester, April 2009

First Received: June 8, 2006 Last Updated: April 20, 2009 History of Changes

Sponsor:	University of Rochester
Collaborators:	Endo Pharmaceuticals EKR Therapeutics, Inc
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00335517

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:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

We will be assessing the pain scores the patients provide the nursing staff currently with each vital signs measurement [ Time Frame: 0-48 hours postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The use of supplemental pain medications, and any adverse events. [ Time Frame: 0-48 hours postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335517

Contacts

Contact: Glenn Rechtine, MD

585-275-8780

glenn_rechtine@urmc.rochester.edu

Locations

United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States, 14642
Contact: Glenn Rechtine, MA glenn_rechtine@urmc.rochester.edu
Principal Investigator: Glenn Rechtine, MD
Sub-Investigator: Paul T Rubery, MD
Sub-Investigator: Robert Molinari, MD
Sub-Investigator: Seth Zeidman, MD

Sponsors and Collaborators

University of Rochester

Endo Pharmaceuticals

EKR Therapeutics, Inc

Investigators

Principal Investigator:

Rechtine Glenn, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Glenn Rechtine, MD )
Study ID Numbers:	11678
Study First Received:	June 8, 2006
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00335517 History of Changes
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

Additional relevant MeSH terms:

Morphine
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010