Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2016-11-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OrthoCarolina Research Institute, Inc.
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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