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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626559
• Other study ID #: IRB_00082660
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: December 8, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• liposomal bupivacaine/plain bupivacaine peri-articular injection
Injection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty.

Locations

Country	Name	City	State
United States	Uutah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Bupivacaine levels		5 minutes to 24 hours after injection	No