A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients
Withdrawn before enrolling · Phase 4
Conditions studied: Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
In brief
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
Key facts
- Study ID
- NCT02765815
- Run by
- Holy Cross Hospital, Florida
- People needed
- 0
- Starts
- 2016-02-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2017-08-09
Who can join
Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 to 88 years of age.
- Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
- Subject willing and able to sign the informed consent.
- Subject is fluent in verbal and written English.
- Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
You may not qualify if…
- Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject has a history of narcotic or alcohol abuse.
- Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
- For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
Where it is running
- Holy Cross Hospital Orthopedic Research Institute — Fort Lauderdale, Florida, United States
Full record on ClinicalTrials.gov
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