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

NCT ID: NCT02626559

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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Conditions

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Anesthesia, Local

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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liposomal bupivacaine/plain bupivacaine peri-articular injection

Injection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Michael Buys

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Uutah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.

Reference Type DERIVED
PMID: 28727583 (View on PubMed)

Other Identifiers

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IRB_00082660

Identifier Type: -

Identifier Source: org_study_id