CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Liposomal Bupivicaine 1.3% +1 moredrug
Likely dose
Liposomal Bupivicaine 1.3% 10mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887650
NCT03887650Phase 4Completed
CompareCT.gov

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

Hartford Hospital·interventional·Posted Mar 25, 2019·Updated Sep 15, 2023

In Brief

A Phase 4 clinical trial evaluating Liposomal Bupivicaine 1.3% and Bupivacaine 0.5% for Post-operative Pain and 3 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartMar 11, 2019
Primary CompletionJan 11, 2022
Study CompletionMar 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.3 years ago

Interventions

Liposomal Bupivicaine 1.3%drug

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

Bupivacaine 0.5%drug

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