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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)

NCT03913091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2022-02-01

Study results available
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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.

Conditions

  • Shoulder Pain

Interventions

DRUG

0.5% Bupivacaine HCL

0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

DRUG

Liposomal Bupivacaine

Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL

Sponsors & Collaborators

Principal Investigators

  • Uchenna Umeh, MD · New York Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-01-19
Completion
2021-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913091 on ClinicalTrials.gov