Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion
NCT ID: NCT03745040
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE4
60 participants
INTERVENTIONAL
2019-01-26
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A: Exparel
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
Liposomal bupivacaine
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
Group B: No Exparel
Standard of Care
No interventions assigned to this group
Interventions
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Liposomal bupivacaine
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receives open, one-level posterior spinal fusion
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Twin Cities Spine Center
OTHER
Allina Health System
OTHER
Responsible Party
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Principal Investigators
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Christopher Alcala-Marquez, MD
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Locations
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Abbott Northwestern Hospital, Allina Health System
Minneapolis, Minnesota, United States
United Hospital, Allina Health System
Saint Paul, Minnesota, United States
Countries
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References
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Tomov M, Tou K, Winkel R, Puffer R, Bydon M, Nassr A, Huddleston P, Yaszemski M, Currier B, Freedman B. Does Subcutaneous Infiltration of Liposomal Bupivacaine Following Single-Level Transforaminal Lumbar Interbody Fusion Surgery Improve Immediate Postoperative Pain Control? Asian Spine J. 2018 Feb;12(1):85-93. doi: 10.4184/asj.2018.12.1.85. Epub 2018 Feb 7.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1252230
Identifier Type: -
Identifier Source: org_study_id