Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

NCT00335517 | Completed Results

• 1 other identifier: 11678
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spine Surgery

Keywords

Lumbar surgery; Surgery L3-S1; DepoDur; Post-operative pain; Pain control; Pain relief

Outcome Measures

Primary Outcomes (1)

• Number of Patients Enrolled and Recieving Injection

  0-48 hours postoperatively

Study Arms (2)

10mg Depodur

EXPERIMENTAL

Drug: DepoDur

15mg DepoDur

EXPERIMENTAL

Drug: DepoDur

Interventions

DepoDur DRUG

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.

10mg Depodur; 15mg DepoDur

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• EKR Therapeutics, Inc: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Glenn Rectine, MD
• Organization: University of Rochester

glenn_rectine@urmc.rochester.edu

585-275-8780

Study Officials

• Rechtine Glenn, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 19, 2014
• Results First Posted: January 9, 2013

Record last verified: 2012-12

Locations

US (1)