Phase 4
Completed N=20
Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty
Arthroplasty, Replacement, Knee · Postoperative Pain
Source: ClinicalTrials.gov NCT02349542 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Adverse Events — 0 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
— | — |
| SECONDARY Plasma Bupivacaine Levels |
0; 0.22; 0.31; 0.35; 0.47; 0.53 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02349542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.