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Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

NCT02349542 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-31

Study results available
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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.

Conditions

  • Arthroplasty, Replacement, Knee
  • Pain

Interventions

DRUG

Liposomal bupivacaine

One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Susan M Odum, PhD · Senior Research Scientist

  • Bryan D Springer, MD · Physician

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-11-01
Completion
2016-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349542 on ClinicalTrials.gov