Liposomal Bupivacaine in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.

Official Title
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Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty

Conditions
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Pain, Postoperative, Arthroplasty, Replacement, Knee, Osteoarthritis

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial Exclusion Criteria: Patients with a sensitivity to marcaine Pregnant or lactating women Non-English speaking individuals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal bupivacaine<br>Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants | Drug: Liposomal bupivacaine<br>* Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline<br>* Other names: Exparel;|
| Active Comparator: bupivacaine HCl, morphine, epinephrine, methylprednisolone<br>Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants | Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone<br>* Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Night of surgery | 
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Post-operative day 1 | 
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Post-operative day 2 | 
| Pain assessment phone call | Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day. | Post-operative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Number of patients with complications | Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days. |