Liposomal Bupivacaine vs Dexamethasone ISB

NCT04047446 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-08-01

Study results available
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Summary

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Conditions

  • Shoulder Pain

Interventions

DRUG

Exparel 133 MG Per 10 ML Injection

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

DRUG

Dexamethasone

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • David Kim, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2021-03-15
Completion
2021-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04047446 on ClinicalTrials.gov