Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

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 knee 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 knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee 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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Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator Exclusion Criteria: Age <18 years Pregnant or breastfeeding Non-English-speaking Unable to give informed consent Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc. Patients unable to complete a device-assisted 140 foot walk at baseline Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone). Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin) Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)

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 |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas. | Drug: Liposomal bupivacaine<br> <br> * Other names: Exparel;|
| Active Comparator: Standard of Care<br>Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone. | Drug: Standard of Care<br>* Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Physical Therapy Sessions Necessary for Discharge | Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission. | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay | VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 
| Length of Stay (LOS, in Days) |  | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 
| Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams) |  | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 
| Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay | Nausea Vomiting Constipation Ileus Pruritus Respiratory depression Over-sedation | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 
| Total Cost of Care (Dollars) |  | Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days. | 
| Hospital Readmission Not Including Admissions Planned Procedures |  | Participants will be followed for 30 days after leaving the hospital. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Total joint arthroplasty, Knee replacement, Osteoarthritis of the knee