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

NCT02626559 | Completed

• 1 other identifier: IRB_00082660
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Serum Bupivacaine levels

  5 minutes to 24 hours after injection

Interventions

liposomal bupivacaine/plain bupivacaine peri-articular injection DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Uutah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.

  PMID: 28727583 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 10, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)