Overview

A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients

Status:
Withdrawn
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Holy Cross Hospital, Florida
Treatments:
Anesthetics
Anesthetics, Local
Bupivacaine
Epinephrine
Epinephryl borate
Ketorolac
Ketorolac Tromethamine
Morphine
Racepinephrine
Criteria
Inclusion Criteria:

1. 18 to 88 years of age.

2. Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.

3. Subject willing and able to sign the informed consent.

4. Subject is fluent in verbal and written English.

5. Subject agrees to take Liposomal bupivacaine or standard of care equivalent.

Exclusion Criteria:

1. Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant
surgery on the study knee and contralateral knee is permitted.

2. Subject is pregnant or planning to become pregnant while enrolled in the study.

3. Subject has a history of narcotic or alcohol abuse.

4. 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).

5. 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.)