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NCT02189317 · ClinicalTrials.gov registry record · Phase 4

Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

A Phase 4 study of Anterior Cruciate Ligament Rupture, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target
1
Study location

NCT02189317 is a Phase 4 study of Anterior Cruciate Ligament Rupture that has completed, run by Emory University. The registered enrollment target is 50 participants, below the 142-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02189317, a Phase 4 study of Anterior Cruciate Ligament Rupture, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.

Conditions Studied

Anterior Cruciate Ligament Rupture

Interventions

  • DRUG Exparel

Study Locations (1)

Georgia

  • Emory University Orthopaedic and Spine Center - Atlanta

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-08
Est. Completion 2015-03
Phase Phase 4

Sponsor

Emory University

1,208 total trials

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What the Registry Record Tells You About NCT02189317

The ClinicalTrials.gov registry entry for NCT02189317 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (65% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Anterior Cruciate Ligament Rupture appearing as the primary indexed condition, and to 1 intervention - of which Exparel is the first listed.

NCT02189317 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT02189317 about?

NCT02189317 is a clinical study titled "Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction". This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into...

What is the current status of trial NCT02189317?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2014-08. Estimated completion is 2015-03.

What conditions does trial NCT02189317 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Rupture.

What interventions are being tested in trial NCT02189317?

The interventions under investigation include: Exparel (DRUG).

Who is sponsoring clinical trial NCT02189317?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02189317 being conducted?

This trial has 1 study location across Georgia. 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

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, or report a data error.