Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Study Overview
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Brief Summary
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This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Detailed Description
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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).

Official Title
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Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation

Conditions
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Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Disc Disease, Lumbar Spondylolisthesis

Intervention / Treatment
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* Drug: Liposomal bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomized clinical trial with two cohorts: one experimental and one control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Exparel<br>Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL). Frequency: Single intraoperative administration | Drug: Liposomal bupivacaine<br>* 20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline<br>* Other names: Exparel;|
| No Intervention: Group B: No Exparel<br>Standard of Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Pain Scores | Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10). | Through study completion, an average of 2.5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Pain | Proportion of pain free subjects, an average of 2.5 days | Through study completion, an average of 2.5 days | 
| Discomfort | Overall Benefit of Analgesia Score. Respondents complete seven questions, each with a score of 0 (minimal or not at all) to 4 (maximum or very much); the total OBAS ranges between 0 (complete relief of pain) and 28 (no benefit). | Through study completion, an average of 2.5 days | 
| Total Opioid Consumption | Total postsurgical opioid consumption in morphine equivalents | Through study completion, an average of 2.5 days | 
| Number of Opioid-related Adverse Events | Average number of opioid-related adverse events per patient | Through study completion, an average of 2.5 days | 
| Patient Cost of In-Hospital Stay | Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy | Through study completion, an average of 2.5 days | 
| Length of Stay | Number of days in the hospital | Through study completion, an average of 2.5 days |