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COMPLETED Phase 4

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

NCT02284386 · View on ClinicalTrials.gov ↗

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

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

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02284386

The ClinicalTrials.gov registry entry for NCT02284386 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02284386 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02284386?

The interventions under investigation include: Bupivacaine SNB (DRUG), EXPAREL Infiltration (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02284386?

This trial is sponsored by Pacira Pharmaceuticals, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial