Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

Completed

Conditions studied: Knee Pain Arthritis

In brief

The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively. Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.

Key facts

Study ID

NCT02276040

Run by

OrthoCarolina Research Institute, Inc.

People needed

26

Starts

2014-10-01

Expected to finish

2017-06-30

Last updated by the study team

2017-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
• At least 18 years of age.

You may not qualify if…

• Allergy to bupivacaine.
• Allergy to epinephrine.
• Patients that are not presenting for a primary TJA
• Patients who are having a TJA without OrthoPAT® auto reinfusion system.
• Patients under age 18.

Where it is running

• OrthoCarolina, PA — Charlotte, North Carolina, United States
• Novant Health Charlotte Orthopedic Hospital — Charlotte, North Carolina, United States
• OrthoCarolina Research Institute, OrthoCarolina, P.A. — Charlotte, North Carolina, United States
• OrthoCarolina, PA — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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