Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

This study will describe postoperative pain management for spine surgery patients receiving
liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a
prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus
liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open
single-level posterior decompression and instrumented fusion for degenerative
spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the
surgical wound, liposomal bupivacaine will be administered to Group A. The administration of
the drug is a study procedure, but note that this is an indicated use of the drug.
Postoperatively, subjects will be assessed for pain and opioid consumption. The
investigator's hypothesis for statistical analysis is that there will be a 30% decrease in
pain medication requirement for the experimental group (Group A: Liposomal bupivacaine )
versus the control group (Group B: No Liposomal bupivacaine).

Inclusion Criteria:

- Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or
spondylolisthesis excluding degenerative disc disease

- Receives open, one-level posterior spinal fusion

Exclusion Criteria:

- Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at
least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral
oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an
equianalgesic dose of another opioid.

- Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and
post-operative data will be excluded from the analysis for these patients.

- Has severe liver disease. Bupivacaine is primarily metabolized in the liver via
conjugation with glucuronic acid. Patients with liver disease, especially severe
disease may be more susceptible to toxicity.

- Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the
kidneys. Excretion can be significantly changed by urinary perfusion, the presence of
renal disease, factors affecting urinary pH, and renal blood flow

- Is less than 18 years old.

- Is pregnant.

- Cannot read and speak English.