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

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.
 
ClinicalTrials.gov Identifier: NCT00335517
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : January 9, 2013
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
Edward Puzas, University of Rochester

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 12, 2006
Results First Submitted Date  ICMJE February 16, 2012
Results First Posted Date  ICMJE January 9, 2013
Last Update Posted Date December 19, 2014
Study Start Date  ICMJE June 2006
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Number of Patients Enrolled and Recieving Injection [ Time Frame: 0-48 hours postoperatively ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
We will be assessing the pain scores the patients provide the nursing staff currently with each vital signs measurement
Change History Complete list of historical versions of study NCT00335517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
The use of supplemental pain medications, and any adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Official Title  ICMJE Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
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.
Detailed Description

Patients will be recruited from the general practices of Drs. Rechtine, Rubery, Molinari, and Zeidman. An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4 cm to L1 level prior to injection. Two milliliters of air will be injected through the catheter to ensure patency. Aspiration will then be done to ensure no intradural injections. Then the undiluted (1 or 1.5 cc) DepoDurTM will be injected.

The type of surgery will be recorded as to

  1. The number of levels of surgery.
  2. The number of levels fused
  3. The number of levels instrumented.
  4. The number of levels with an interbody fusion
  5. Time to ambulate
  6. Time to use oral analgesics
  7. The time of DepoDur injection.
  8. The amount of pain medications used in the 0-2 hour time interval after injection, 2-4 hours, and each subsequent 4 hour interval.
  9. Pain scores will be recorded with vital signs. (The pain score is from 1 to 10 and is asked orally to patients. This is part of the standard of care).

In a one-to-one randomization, patients will receive either a 10 or 15 mg dose of DepoDur at the time of surgery

Each patient will be provided with a morphine PCA (patient controlled analgesia) system postoperatively and then oral analgesics as appropriate. Analgesic requirements in morphine equivalents will be recorded. Comparison between the 10 and 15 mg dose will be done as to analgesic effectiveness and safety.

Post-operative orders (for 48 hours) will include epidural narcotic protocol to include. The following post-operative orders are standard of care.

  1. Patient's bedside and chart will be identified as "spinal narcotic".
  2. Head of bed maintained at 30 degrees of elevation.
  3. 0.4 mg of Narcan (naloxone) will be added to each liter of IV fluid
  4. Counted respirations and pupil size to be included with vital signs
  5. Pain scores with vital signs (The pain score is from 1 to 10 and is asked orally to patients. This is part of the standard of care).
  6. Continuous pulse oxymetry measurement
  7. Call House officer for respiratory rate of <8 minute or changes in saturation as measured by pulse oxymetry.

Current post-operative PCA orders usually start with 1 mg of morphine per cc with a seven to ten minute lockout. Based on work by Rawal [2-3], who demonstrated that small doses of Naloxone could help eliminate nuisance side effects of epidural narcotics such as localized pruritis, 0.4 mg of Naloxon will be added to each liter of IV fluid. Continuous pulse oxymetry should be used to monitor the patient's respiratory function for 48 hours after the last dose of the epidural narcotic. Post-operative vital signs will be obtained in the recovery room by anesthesia policy. Once the patient is transferred to the floor, vital signs would be obtained every hour for the first four hours and every four hours after that.

The standard of care involves providing patients after lumbar surgery with the best pain relief possible. This can be done in a number of different ways. The use of Duramorph has been possible for many years. It has not been used recently only because of the need to re-dose. The pain relief provided by the epidural narcotic is detailed in the literature. What will be altered through this study is the addition of the long acting epidural narcotic, DepoDur. This will potentially provide for sustained pain relief for 48 hours. Usually by 48 hours postoperatively, the patient is starting to improve to a point of being able to be maintained on oral analgesics. The remainder of the study is consistent with standard of care for epidural narcotics.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spine Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 10mg Depodur
    Intervention: Drug: DepoDur
  • Experimental: 15mg DepoDur
    Intervention: Drug: DepoDur
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2010)
98
Original Enrollment  ICMJE
 (submitted: June 8, 2006)
100
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335517
Other Study ID Numbers  ICMJE 11678
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward Puzas, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE EKR Therapeutics, Inc
Investigators  ICMJE
Principal Investigator: Rechtine Glenn, MD University of Rochester
PRS Account University of Rochester
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP