N/A
Completed N=26
Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty
Knee Pain Arthritis
Source: ClinicalTrials.gov NCT02276040 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Change in Blood Serum Levels of Bupivocaine From Baseline — 0.6; 0.95; 0.8 ug/cc
Summary
The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively.
Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Serum Levels of Bupivocaine From Baseline |
0.6; 0.95; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
- At least 18 years of age.
Exclusion Criteria
- Allergy to bupivacaine.
- Allergy to epinephrine.
- Patients that are not presenting for a primary TJA
- Patients who are having a TJA without OrthoPAT® auto reinfusion system.
- Patients under age 18.
Data sourced from ClinicalTrials.gov (NCT02276040). 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.