Clinical trial NCT03745040: Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion
Official title: Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Lumbar Disc Herniation
Lumbar Disc Disease
Lumbar Spondylolisthesis
Lead sponsor: Allina Health System
Sponsor class: OTHER
Collaborators: name: Twin Cities Spine Center
First posted: 2018-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized clinical trial with two cohorts: one experimental and one control.
Primary purpose: TREATMENT

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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Pain Scores
timeFrame: Through study completion, an average of 2.5 days
Secondary outcomes:
measure: Number of Participants with Pain
timeFrame: Through study completion, an average of 2.5 days
measure: Discomfort
timeFrame: Through study completion, an average of 2.5 days
measure: Total Opioid Consumption
timeFrame: Through study completion, an average of 2.5 days
measure: Number of Opioid-related Adverse Events
timeFrame: Through study completion, an average of 2.5 days
measure: Patient Cost of In-Hospital Stay
timeFrame: Through study completion, an average of 2.5 days
measure: Length of Stay
timeFrame: Through study completion, an average of 2.5 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital, Allina Health System
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital, Allina Health System
state: Minnesota
Study officials:
affiliation: Allina Health System
name: Christopher Alcala-Marquez, MD
role: PRINCIPAL_INVESTIGATOR
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