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NCT04974385 · ClinicalTrials.gov registry record · Phase 3

Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

A Phase 3 study of Analgesia, sponsored by University of Virginia.

Completed
Registry status
Phase 3
Development phase
80
Enrollment target
1
Study location

NCT04974385: Completed Phase 3 study of Analgesia, sponsored by University of Virginia.

NCT04974385 is a Phase 3 study of Analgesia that has completed, run by University of Virginia. The registered enrollment target is 80 participants, below the 89-participant average among 19 other Analgesia trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04974385, a Phase 3 study of Analgesia, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 3
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

Primary Outcome

Morphine equivalents used during first 72 hours after surgery

Conditions Studied

Interventions

  • DRUG Bupivacaine
  • DRUG Liposomal bupivacaine

Study Locations (1)

Virginia

  • University of Virginia Medical Center - Charlottesville

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2021-08-04
Est. Completion 2022-05-04
Phase Phase 3
University of Virginia

449 total trials

What the finished NCT04974385 record still lists

NCT04974385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 89-participant average among 19 other Analgesia trials with a reported enrollment target (10% lower).

The record links to 1 condition, with Analgesia appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.

NCT04974385 reports a single indexed study location in Virginia.

Frequently Asked Questions

What is clinical trial NCT04974385 about?

NCT04974385 is a clinical study titled "Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty". The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain ...

What is the current status of trial NCT04974385?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2021-08-04. Estimated completion is 2022-05-04.

What conditions does trial NCT04974385 study?

This clinical trial studies the following conditions: Analgesia.

What interventions are being tested in trial NCT04974385?

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

Who is sponsoring clinical trial NCT04974385?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04974385 being conducted?

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

Similar trials for Analgesia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04974385's enrollment target sits among peer trials

80 12th of 19 higher than 7 of 19 other Analgesia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Analgesia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04974385, the US trial registry maintained by the National Library of Medicine. NCT04974385 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.