Total Knee Arthroplasty, Pain Management
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Exparel, Cocktail Injection, Pain Management
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.
Interventions
Sponsors
Arthroplasty Foundation, Inc.
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed