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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02571283
• Other study ID #: 14.1276
• Status: Withdrawn
• Phase: Phase 4
• First received: September 28, 2015
• Last updated: April 5, 2017
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained

• The subject underwent a primary total knee replacement under adductor canal block with general anesthesia

Exclusion Criteria:

• The subject is a minor

• The subject is on chronic narcotics

• The subject has an indwelling pain pump

• The subject is having a knee revision surgery

• The subject is having a partial knee replacement

• The subject has a history of sepsis in a previously replaced joint

• The subject has back pain

• The subject has radicular pain

• The subject suffers from depression

• The subject has fibromyalgia

• The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims

Related Conditions & MeSH terms

• Pain Management
• Total Knee Arthroplasty

Intervention

Drug:
• Cocktail
Administered as a single dose injection.
• Exparel
Administered 20 minutes+ before additional medications.
• Marcaine
Administered 20 minutes or more after Exparel is administered.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Arthroplasty Foundation, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively.		Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.