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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exparel plus multi-drug cocktail

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

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine, 266mg

Intervention Type DRUG

Ketorolac 30mg

Intervention Type DRUG

Morphine 10mg

Intervention Type DRUG

Bupivacaine 0.25% with Epinephrine

Intervention Type DRUG

Multi-drug cocktail alone

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.5 % with Epinephrine

Intervention Type DRUG

Ketorolac 30mg

Intervention Type DRUG

Morphine 10mg

Intervention Type DRUG

Interventions

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Liposomal bupivacaine, 266mg

Intervention Type DRUG

Bupivacaine 0.5 % with Epinephrine

Intervention Type DRUG

Ketorolac 30mg

Intervention Type DRUG

Morphine 10mg

Intervention Type DRUG

Bupivacaine 0.25% with Epinephrine

Intervention Type DRUG

Other Intervention Names

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Exparel Injection

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No