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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 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.

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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.

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

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT04974385

The ClinicalTrials.gov registry entry for NCT04974385 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 89-participant average among 19 other Analgesia trials with a reported enrollment target (10% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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

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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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