Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

Completed · Phase 4

Conditions studied: Arthroplasty, Replacement, Knee, Pain

In brief

The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the use of a standardized periarticular injection containing free bupivacaine and liposomal bupivacaine.

Key facts

Study ID

NCT02349542

Run by

OrthoCarolina Research Institute, Inc.

People needed

20

Starts

2015-01-01

Expected to finish

2016-11-21

Last updated by the study team

2017-08-31

Who can join

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

You may qualify if…

• Patients deemed appropriate candidates for simultaneous bilateral total knee arthroplasty.
• Patients receiving general anesthesia
• Understands the local language and is willing and able to follow the requirements of the protocol
• Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

You may not qualify if…

• Patients less than 18 years of age
• Allergy to bupivacaine
• Allergy to epinephrine
• Patients who are not medically cleared to undergo bilateral total knee replacement surgery, or
• Patient-reported liver impairment (per investigator discretion)
• Patient-reported renal impairment (per investigator discretion)
• Patients receiving spinal anesthesia
• Females who are pregnant or lactating

Where it is running

• OrthoCarolina, PA — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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