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

Osteoarthritis, Knee Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT02765815
• Study type: Interventional
• Source: Holy Cross Hospital, Florida
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2016
• Completion date: January 2017