NCT02765815

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

A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Holy Cross Hospital, Florida · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee
• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine, 266mg
DRUG	Bupivacaine 0.5 % with Epinephrine
DRUG	Ketorolac 30mg
DRUG	Morphine 10mg
DRUG	Bupivacaine 0.25% with Epinephrine

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-05-09
• Last updated: 2017-08-09

Locations

1 site across 1 country: United States