Trials / Suspended
SuspendedNCT03745040
Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion
Does Liposomal Bupivacaine Improve Postoperative Pain Control After One Level Posterior Spinal Fusion With Instrumentation
- Status
- Suspended
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Allina Health System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liposomal bupivacaine | 20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline |
Timeline
- Start date
- 2019-01-26
- Primary completion
- 2021-09-20
- Completion
- 2028-08-01
- First posted
- 2018-11-19
- Last updated
- 2024-12-11
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03745040. Inclusion in this directory is not an endorsement.