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NCT05900427 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty, sponsored by Johnny K. Lee.

Recruiting
Registry status
Phase 4
Development phase
120
Enrollment target
1
Study location

NCT05900427 is a Phase 4 study of Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty that is actively recruiting participants, run by Johnny K. Lee. The registered enrollment target is 120 participants, below the 210-participant average among 3 other Reverse Total Shoulder Arthroplasty trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05900427, a Phase 4 study of Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty, is actively recruiting participants, sponsored by Johnny K. Lee.

RECRUITING
Registry status
Phase 4
Development phase
120 participants
Enrollment target
1
Study location

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).

Interventions

  • DRUG Bupivacaine
  • DRUG Liposomal bupivacaine

Study Locations (1)

Illinois

  • NorthShore University HealthSystem - Skokie

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-09-08
Est. Completion 2026-03-01
Phase Phase 4

Sponsor

Johnny K. Lee

1 total trials

What the Registry Record Tells You About NCT05900427

The ClinicalTrials.gov registry entry for NCT05900427 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 3 other Reverse Total Shoulder Arthroplasty trials with a reported enrollment target (43% lower). The listed sponsor is Johnny K. Lee, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Reverse Total Shoulder Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.

NCT05900427 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT05900427 about?

NCT05900427 is a clinical study titled "Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients". 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 int...

What is the current status of trial NCT05900427?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-09-08. Estimated completion is 2026-03-01.

What conditions does trial NCT05900427 study?

This clinical trial studies the following conditions: Reverse Total Shoulder Arthroplasty, Total Shoulder Arthroplasty.

What interventions are being tested in trial NCT05900427?

The interventions under investigation include: Bupivacaine (DRUG), Liposomal bupivacaine (DRUG).

Who is sponsoring clinical trial NCT05900427?

This trial is sponsored by Johnny K. Lee, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05900427 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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