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NCT03845894 · ClinicalTrials.gov registry record · Phase 4

Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

A Phase 4 study, sponsored by Wake Forest University Health Sciences.

Terminated
Registry status
Phase 4
Development phase
25
Enrollment target

NCT03845894: Clinical Trial Phase 4 study, sponsored by Wake Forest University Health Sciences.

NCT03845894 is a Phase 4 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03845894, a Phase 4 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.

TERMINATED
Registry status
Phase 4
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Primary Outcome

Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.

Interventions

  • DRUG Liposomal bupivacaine
  • DRUG Bupivacaine with adjuvants

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-03-03
Est. Completion 2022-06-25
Phase Phase 4
Wake Forest University Health Sciences

1,140 total trials

Why NCT03845894 stopped before completion

NCT03845894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Liposomal bupivacaine is the first listed.

NCT03845894 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03845894 about?

NCT03845894 is a clinical study titled "Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants". The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

What is the current status of trial NCT03845894?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2020-03-03. Estimated completion is 2022-06-25.

What interventions are being tested in trial NCT03845894?

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

Who is sponsoring clinical trial NCT03845894?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03845894's enrollment target sits among peer trials

25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT03845894, the US trial registry maintained by the National Library of Medicine. NCT03845894 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.