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NCT02284386 · ClinicalTrials.gov registry record · Phase 4

Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty

A Phase 4 study of Pain, sponsored by Pacira Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target
2
Study locations

NCT02284386: Completed Phase 4 study of Pain, sponsored by Pacira Pharmaceuticals.

NCT02284386 is a Phase 4 study of Pain that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 15 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02284386, a Phase 4 study of Pain, has completed, sponsored by Pacira Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target
2
Study locations

Study Summary

This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.

Conditions Studied

Pain

Interventions

  • DRUG Bupivacaine SNB
  • DRUG EXPAREL Infiltration

Study Locations (2)

Alabama

  • Shaols Medical Trials, Inc. - Sheffield

Minnesota

  • University of Minnesota Medical Center - Fairview, West Bank - Minneapolis

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-12
Est. Completion 2015-03
Phase Phase 4

Sponsor

Pacira Pharmaceuticals

88 total trials

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What the Registry Record Tells You About NCT02284386

The ClinicalTrials.gov registry entry for NCT02284386 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (95% lower). The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.

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

NCT02284386 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Minnesota.

Frequently Asked Questions

What is clinical trial NCT02284386 about?

NCT02284386 is a clinical study titled "Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Total Knee Arthroplasty". This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL loc...

What is the current status of trial NCT02284386?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2014-12. Estimated completion is 2015-03.

What conditions does trial NCT02284386 study?

This clinical trial studies the following conditions: Pain.

What interventions are being tested in trial NCT02284386?

The interventions under investigation include: Bupivacaine SNB (DRUG), EXPAREL Infiltration (DRUG).

Who is sponsoring clinical trial NCT02284386?

This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02284386 being conducted?

This trial has 2 study locations across Alabama, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.