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

Holy Cross Hospital, Florida

Status and phase: Withdrawn; Phase 4

Conditions: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee

Treatments: Drug: Liposomal bupivacaine, 266mg; Drug: Bupivacaine 0.5 % with Epinephrine; Drug: Morphine 10mg; Drug: Ketorolac 30mg; Drug: Bupivacaine 0.25% with Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02765815

Exparel TKA

Details and patient eligibility

About

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.

Full description

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. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.

This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Exparel plus multi-drug cocktail

Active Comparator group

Description:

Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.

Treatment:

Drug: Bupivacaine 0.25% with Epinephrine

Drug: Morphine 10mg

Drug: Ketorolac 30mg

Drug: Liposomal bupivacaine, 266mg

Multi-drug cocktail alone

Active Comparator group

Description:

Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.

Treatment:

Drug: Morphine 10mg

Drug: Ketorolac 30mg

Drug: Bupivacaine 0.5 % with Epinephrine