NCT02571283

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Total Knee Arthroplasty
• Pain Management

Interventions

Type	Name	Description
DRUG	Cocktail	Administered as a single dose injection.
DRUG	Exparel	Administered 20 minutes+ before additional medications.
DRUG	Marcaine	Administered 20 minutes or more after Exparel is administered.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-10-08
• Last updated: 2017-04-06