Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study

Conditions
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Osteoarthritis, Total Knee Arthroplasty, Pain Management

Intervention / Treatment
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* Drug: Pain Cocktail with Exparel
* Drug: Pain Cocktail with Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain Cocktail with Ropivacaine<br>patients given the standard intra-articular pain cocktail injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation. given in one single dose | Drug: Pain Cocktail with Ropivacaine<br>* pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.<br>|
| Experimental: Pain Cocktail with Exparel<br>patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc. given in one single dose | Drug: Pain Cocktail with Exparel<br>* 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.<br>* Other names: liposomal bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | oral and intravenous narcotic consumption is recorded during hospital stay | immediately post-operatively through hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours to ambulate 100 feet |  | immediately post-operatively through hospital stay | 
| Length of hospital stay (hours) | Number of hours the patient stays at the hospital following operation | immediately post-operatively through hospital stay | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management