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Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients

NCT05900427 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-04-29

No results posted yet for this study

Summary

The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.

This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).

Conditions

  • Total Shoulder Arthroplasty
  • Reverse Total Shoulder Arthroplasty

Interventions

DRUG

Liposomal bupivacaine

Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).

DRUG

Bupivacaine

Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.

Sponsors & Collaborators

  • Endeavor Health

    collaborator OTHER

  • Johnny K. Lee

    lead OTHER

Principal Investigators

  • Johnny K Lee, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2025-10-05
Completion
2025-12-01
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 NCT05900427 on ClinicalTrials.gov