CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 184 enrolled
Drug / intervention
Liposomal Bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03913091
NCT03913091Phase 4Completed

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)

NYU Langone Health·interventional·Posted Apr 12, 2019·Updated Feb 1, 2022

In Brief

A Phase 4 clinical trial evaluating Liposomal Bupivacaine and 0.5% Bupivacaine HCL for Shoulder Pain. Completed, enrolled 184 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShoulder Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 12, 2019
Enrollment StartMar 1, 2019
Primary CompletionJan 19, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.2 years ago

Interventions

Liposomal Bupivacainedrug

Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL

0.5% Bupivacaine HCLdrug

0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)