Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

Specific Aim #1: To compare the postoperative pain levels of single level lumbar fusion
patients treated with either MMA pain management protocol or standard pain management
protocol.

Controlling postoperative pain is a critical first step in facilitating a patient's recovery
and improved quality of life. In-hospital pain levels will be measured using a numeric pain
scale on a scale of 0-10. Pain assessment is conducted by the hospital nurses as a standard
of care protocol. Assessments are every four to six hours, within 60 minutes after receiving
a pain medication

Hypothesis: Patients treated with the MMA pain protocol will have significantly less
immediate postoperative pain as compared to patients treated with the standard pain protocol.

Specific Aim #2: To compare the immediate postoperative, or in-hospital, narcotic consumption
of single level lumbar fusion patients treated with either MMA pain management protocol or
standard pain management protocol.

Decreasing narcotic consumption following lumbar spinal fusion surgery is important for
faster recovery for the patient, decreasing narcotic related side effects (nausea and
vomiting, lethargy, ileus, etc) as well as lowering overall treatment costs. The total amount
of narcotic use during the course of the hospitalization for each subject will be recorded.
Dosages of narcotics will be converted to morphine equivalents.

Hypothesis: Patients treated with the MMA pain protocol will consume significantly less
immediate postoperative narcotic pain medications compared to patients treated with the
standard pain protocol.

Specific Aim #3: To compare the length of hospital stay of single level lumbar fusion
patients treated with either MMA pain management protocol or standard pain management
protocol.

Decreasing the amount of time patients remain in the hospital may decrease the time it takes
a patient to return to personal and societal responsibilities. Additionally it reduces the
patients risk of a nosocomial infection and reduces the costs of the surgery.

Hypothesis: Patients treated with the MMA pain protocol will have a significantly reduced
length of stay in the hospital compared to patients treated with the standard pain protocol.

Specific Aim #4: To compare postoperative quality of life of single level lumbar fusion
patients treated with either MMA pain management protocol or standard pain management
protocol.

The primary purpose of lumbar fusion surgery is to improve the quality of life for patients.
The Oswestry Disability Index (ODI) will be used as a disease specific measure. The Veterans
Rand 12 (VR-12) will be used as a general health outcome measure. Each of these patient
reported outcome measures will be collected pre-operatively and at each of the following
postoperative visits: 2 weeks, 6 weeks, 3 month, 6 visit, 1 visit, and 2 year.

Hypothesis: Patients treated with the MMA pain protocol will have significantly greater
improvement in Quality of Life measures compared to patients treated with the standard pain
protocol and this will be sustained out to two years post-operatively.

Inclusion Criteria:

1. Subjects undergoing a single level lumbar decompression and fusion

2. > 18 years of age and < 70 years of age

3. The subject is willing and able to understand, sign and date the study specific
patient informed consent and HIPAA authorization to volunteer participation in the
study

Exclusion Criteria:

1. Patients with liver disease (documented liver function test abnormality)

2. Patients with renal disease (documented glomerular filtration rate < 60mL/min/1.73m2)

3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine
equivalents/day.

4. Patients with active alcohol dependence

5. Patients with active illicit drug dependence

6. Patients < 18 years of age and >70 years of age

7. Patients allergic to any medication given in either arm (list medications)

8. Patients who have a seizure disorder