Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

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.