Clinical trial NCT02571283: Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
Official title: A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Pain Management
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Exparel
Cocktail Injection
Pain Management
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Arthroplasty Foundation, Inc.
First posted: 2015-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: