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NCT03913091 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 184
- Enrollment target
NCT03913091: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT03913091 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 184 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913091, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 184 participants
- Enrollment target
Study Summary
This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.
Primary Outcome
Measure in morphine milligram equivalents \[MME\]
Interventions
- DRUG Liposomal Bupivacaine
- DRUG 0.5% Bupivacaine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2021-01-19 |
| Phase | Phase 4 |
What the finished NCT03913091 record still lists
NCT03913091 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Liposomal Bupivacaine is the first listed.
NCT03913091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913091 about?
NCT03913091 is a clinical study titled "Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)". This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulde...
What is the current status of trial NCT03913091?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 184 participants. The study started on 2019-03-01. Estimated completion is 2021-01-19.
What interventions are being tested in trial NCT03913091?
The interventions under investigation include: Liposomal Bupivacaine (DRUG), 0.5% Bupivacaine HCL (DRUG).
Who is sponsoring clinical trial NCT03913091?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913091's enrollment target sits among peer trials
184 460th of 2000 higher than 1,538 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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