Lumbar Spinal Stenosis Clinical Trial
Official title:
Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
NCT number | NCT03745040 |
Other study ID # | 1252230 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 26, 2019 |
Est. completion date | May 2024 |
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Abbott Northwestern Hospital, Allina Health System | Minneapolis | Minnesota |
United States | United Hospital, Allina Health System | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System | Twin Cities Spine Center |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Total Opioid Consumption | Total postsurgical opioid consumption in morphine equivalents | Through study completion, an average of 2.5 days | |
Secondary | Number of Opioid-related Adverse Events | Average number of opioid-related adverse events per patient | Through study completion, an average of 2.5 days | |
Secondary | 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 | |
Secondary | Length of Stay | Number of days in the hospital | Through study completion, an average of 2.5 days |
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