Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
Who is this study for? Patients undergoing one level posterior spinal fusion
What treatments are being studied? Bupivacaine
Status: Suspended
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
Abbott Northwestern Hospital, Allina Health System
Minneapolis
United Hospital, Allina Health System
Saint Paul
Time Frame
Start Date: 2019-01-26
Completion Date: 2028-08
Participants
Target number of participants: 60
Treatments
Experimental: 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
No_intervention: Group B: No Exparel
Standard of Care
Related Therapeutic Areas
Sponsors
Collaborators: Twin Cities Spine Center
Leads: Allina Health System