NCT03887650

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-03-11
• Primary completion: 2022-01-11
• Completion: 2022-03-08
• First posted: 2019-03-25
• Last updated: 2023-09-15
• Results posted: 2023-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study