Serum Bupivacaine Concentration Levels After Injection of Liposomal Bupivacaine Into the Knee

December 8, 2016 updated by: Michael Buys, University of Utah

Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty

Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Uutah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

Description

Inclusion Criteria:

  • Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

Exclusion Criteria:

  • Known hepatic dysfunction or renal insufficiency (creatinine > 1.5 mg/dL);
  • allergy to the study medications;
  • pregnancy;
  • incarceration;
  • inability to communicate with the investigators;
  • morbid obesity (body mass index > 40 kg/m2).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Bupivacaine levels
Time Frame: 5 minutes to 24 hours after injection
5 minutes to 24 hours after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00082660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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