Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 184 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913091
The ClinicalTrials.gov registry entry for NCT03913091 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liposomal Bupivacaine is the first listed.
NCT03913091 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.