Osteoarthritis, Pain Management, Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management
Brief summary
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach? The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.
Detailed description
The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.
Interventions
DRUGPain Cocktail with Exparel
pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.
DRUGPain Cocktail with Ropivacaine
pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
Sponsors
DeClaire LaMacchia Orthopaedic Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire * 18 years of age or older * Primary diagnosis of osteoarthritis of the knee * Opioid naïve patient (according to FDA guidelines)
Exclusion criteria
* Prior knee replacement * Prior use of narcotics for chronic pain management * Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.) * Unicompartmental knee replacement * Bilateral Total Knee Arthroplasty * Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least: \> 60 mg oral morphine/day \> 25μg transdermal fentanyl/hour \> 30 mg oral oxycodone/day \> 8 mg oral hydromorphone/day \> 25 mg oral oxymorphone/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | immediately post-operatively through hospital stay | oral and intravenous narcotic consumption is recorded during hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hours to ambulate 100 feet | immediately post-operatively through hospital stay | — |
| Length of hospital stay (hours) | immediately post-operatively through hospital stay | Number of hours the patient stays at the hospital following operation |
| Visual Analog Pain Score | day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively | — |
| Knee Society Score | 3 months, 6 months, 1 year postoperatively | — |
Outcome results
None listed