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Withdrawn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: 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

  • 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.

Exclusion criteria

  • 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.)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems