Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | June 8, 2006 | ||||
Last Updated Date | April 20, 2009 | ||||
Start Date † | June 2006 | ||||
Current 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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00335517 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
The use of supplemental pain medications, and any adverse events. [ Time Frame: 0-48 hours postoperatively ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients | ||||
Official Title † | 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
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.
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 Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Lumbar Spine Surgery | ||||
Intervention † | Drug: DepoDur | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 100 | ||||
Estimated Completion Date | August 2009 | ||||
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Patients who experience complications during the surgery (e.g., major hemorrhage, dural puncture) will not receive the study drug. |
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
|
||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00335517 | ||||
Responsible Party | Glenn Rechtine, MD, University of Rochester | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Rochester | ||||
Collaborators †† |
|
||||
Investigators † |
|
||||
Information Provided By | University of Rochester | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |