Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.

Detailed Description
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Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Official Title
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Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Standard of care analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of osteoarthritis Elected to undergo primary TKA, THA, or TSA Exclusion Criteria: Age < 18 years Pregnant or breastfeeding Non-English speaking Unable to give informed consent Previous open hip, knee or shoulder surgery Pre-determined patients discharging to ECF Patients with allergies to bupivacaine Patients currently taking opioid pain medication Patients with contraindication to nerve blocks Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site Patients with severe hepatic disease Patients with chronic heart disease as defined as a decreased ejection fraction

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care analgesia<br>Total Hip Arthroplasty (THA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Knee Arthroplasty (TKA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Shoulder Arthroplasty (TSA): All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. | Drug: Standard of care analgesia<br> <br> * Other names: Epinephrine;|
| Experimental: Liposomal bupivacaine<br>THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle | Drug: Liposomal bupivacaine<br> <br> * Other names: Exparel;Drug: Standard of care analgesia<br> <br> * Other names: Epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in Hospital (Days) |  | Participants were followed for the duration of hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Post-operative Rescue Opioids (Hours) |  | Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days | 
| Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days |  | Date of discharge through 30 days following discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement