Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
This study is ongoing, but not recruiting participants.
Sponsor:
University of Rochester
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00335517
First received: June 8, 2006
Last updated: January 25, 2012
Last verified: January 2012
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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:
- 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 ]
Enrollment: | 98 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | November 2012 |
Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Show Detailed Description-
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.
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
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
Keywords provided by University of Rochester:
ClinicalTrials.gov processed this record on October 16, 2012
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 |
Last Updated: | January 25, 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 October 16, 2012