CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
Bupivacaine HCl +1 moredrug
Likely dose
Bupivacaine HCl 20 mLfrom 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/NCT05005260
NCT05005260Phase 4Completed

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

Mayo Clinic·interventional·Posted Aug 13, 2021·Updated May 7, 2024

In Brief

A Phase 4 clinical trial evaluating Bupivacaine HCl and Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj for Pain, Postoperative and Brachial Plexus Block. Completed, enrolled 88 participants across 1 site.

Detailed Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 13, 2021
Enrollment StartOct 14, 2021
Primary CompletionMar 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.9 years ago

Interventions

Bupivacaine HCldrug

Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.

Liposomal bupivacaine + Bupivacaine Hcl 0.5% Injdrug

Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).