A Phase 4 interventional study of Liposomal bupivacaine in Lumbar Spinal Stenosis, Lumbar Disc Herniation and Lumbar Disc Disease, sponsored by Allina Health System. Suspended at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Allina Health System · Phase 4, Interventional, and Treatment
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
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).
Exclusion Criteria:
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
Drug: Liposomal bupivacaine
Standard of Care
20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
Also known as: Exparel
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).
Time frame: Through study completion, an average of 2.5 days
Number of Participants with Pain
Proportion of pain free subjects, an average of 2.5 days
Time frame: Through study completion, an average of 2.5 days
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).
Time frame: Through study completion, an average of 2.5 days
Total Opioid Consumption
Total postsurgical opioid consumption in morphine equivalents
Time frame: Through study completion, an average of 2.5 days
Number of Opioid-related Adverse Events
Average number of opioid-related adverse events per patient
Time frame: Through study completion, an average of 2.5 days
Patient Cost of In-Hospital Stay
Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy
Time frame: Through study completion, an average of 2.5 days
Length of Stay
Number of days in the hospital
Time frame: Through study completion, an average of 2.5 days
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Plan to share: No — There is not a plan to make IPD available.
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Allina Health System