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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: Recruiting Phase 4 study of Reverse Total Shoulder Arthroplasty and Total Shoulder Arthroplasty, sponsored by Johnny K. Lee.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The investigators will collect the difference in the proportion of patients with clinically significant tolerable pain scores (defined as Visual Analogue Scale (VAS) ≤ 4) Postoperative Day 1 in those patients receiving an interscalene block with liposomal bupivacaine with plain bupivacaine vs. plain bupivacaine. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Liposomal bupivacaine
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Skokie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-09-08 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 4 |
What NCT05900427 shows while recruiting
NCT05900427 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 210-participant average among 3 other Reverse Total Shoulder Arthroplasty trials with a reported enrollment target (43% lower).
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 a single indexed study location in 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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