MedTrace Logo

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

NCT03887650 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-15

Study results available
· View outcomes & findings →

Summary

This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.

Conditions

  • Post-operative Pain
  • Total Shoulder Arthroplasty
  • Osteoarthritis of the Shoulder
  • Pain Management

Interventions

DRUG

Liposomal Bupivicaine 1.3%

10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block

DRUG

Bupivacaine 0.5%

20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Kevin Finkel, MD · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2022-01-11
Completion
2022-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03887650 on ClinicalTrials.gov