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Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

NCT03845894 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-11-13

Study results available
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Summary

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Conditions

  • Shoulder Arthroplasty

Interventions

DRUG

Liposomal bupivacaine

Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

DRUG

Bupivacaine with adjuvants

Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Doug Jaffe, DO · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2022-06-25
Completion
2022-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03845894 on ClinicalTrials.gov