Lumbar Spine Surgery Clinical Trial
Official title:
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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