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OpenTrials
Completed

NCT Number: NCT02626559

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

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

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Key information

Conditions

Anesthesia, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uutah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

liposomal bupivacaine/plain bupivacaine peri-articular injection

Drug

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

Primary outcomes

  1. Serum Bupivacaine levels

    Time frame: 5 minutes to 24 hours after injection

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2015
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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