Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

Total Knee Arthroplasty Clinical Trial

Official title: A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel

Status Withdrawn

Clinical Trial Summary

A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:

1. a local cocktail.

2. a local cocktail plus Exparel.

3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

Clinical Trial Description

As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.

Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:

1. a local cocktail.

2. a local cocktail plus Exparel.

3. marcaine plus Exparel prior to wound closure following knee arthroplasty.

METHODOLOGY

Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals. ;

Related Conditions & MeSH terms

• Pain Management
• Total Knee Arthroplasty

• NCT number: NCT02571283
• Study type: Interventional
• Source: University of Louisville
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2015
• Completion date: May 2016