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| Name | Class |
|---|---|
| EKR Therapeutics, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10mg Depodur | Experimental |
| |
| 15mg DepoDur | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Enrolled and Recieving Injection | 0-48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Rechtine Glenn, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injection | DepoDur Injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Injection | DepoDur Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Enrolled and Recieving Injection | Posted | Number | participants | 0-48 hours postoperatively |
|
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injection | DepoDur Injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Draning Incision | Infections and infestations | Non-systematic Assessment | 2 participants were readmitted and returned to the OR for irrigation, debridement, and reclosure of draining incision. One patient returned post operatively on day 11 and the other on day 19. All cultures were negative for infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Rectine, MD | University of Rochester | 585-275-8780 | glenn_rectine@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 98 |
| 5 |
| 98 |
|
| Pulmonary embolus | Cardiac disorders | Non-systematic Assessment | Patient diagnosed with a pulmonary embolus on post-op day 1. Patient had a history of atrial fibrillation treated with warfarin. Patient was treated with IVC filters and heparin anticoagulation, restarted on warfarin and discharged home. |
|
| Coronary atery disease | Cardiac disorders | Non-systematic Assessment | One patient with a history of coronary artery disease was discharged to rehab facility where they died five days after srugery secondary to a myocardial infarction |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |