Lumbar Disc Disease, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
Conditions
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).
Interventions
DRUGLiposomal bupivacaine
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
Sponsors
Twin Cities Spine Center
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded and will not be informed if they received the study drug or not.
Intervention model description
This is a prospective randomized clinical trial with two cohorts: one experimental and one control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Pain Scores | Through study completion, an average of 2.5 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort | Through study completion, an average of 2.5 days | 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). |
| Total Opioid Consumption | Through study completion, an average of 2.5 days | Total postsurgical opioid consumption in morphine equivalents |
| Number of Participants with Pain | Through study completion, an average of 2.5 days | Proportion of pain free subjects, an average of 2.5 days |
| Patient Cost of In-Hospital Stay | Through study completion, an average of 2.5 days | Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy |
| Length of Stay | Through study completion, an average of 2.5 days | Number of days in the hospital |
| Number of Opioid-related Adverse Events | Through study completion, an average of 2.5 days | Average number of opioid-related adverse events per patient |
Countries
United States
Outcome results
None listed