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

H

Holy Cross Hospital, Florida

Status and phase

Withdrawn
Phase 4

Conditions

Arthroplasty, Replacement, Knee
Osteoarthritis, Knee

Treatments

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

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

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: Bupivacaine 0.5 % with Epinephrine
Drug: Morphine 10mg
Drug: Ketorolac 30mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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