Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Official Title
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A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Drug: Liposome Bupivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥18 years of age Scheduled to undergo primary unilateral TKA under general anesthesia. American Society of Anesthesiology (ASA) Physical Status I-III Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Planned concurrent surgical procedure (e.g., bilateral TKA). Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine). Previous participation in a liposome bupivacaine study. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposome Bupivacaine<br>Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline | Drug: Liposome Bupivacaine<br>* 10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline<br>* Other names: Exparel;|
| Active Comparator: Bupivacaine<br>Single shot femoral nerve block with 20cc of 0.25% bupivacaine | Drug: Bupivacaine<br>* 20 cc of 0.25% bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption | Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative VAS scores | Patients will be asked to describe the pain intensity under two circumstances: pain at rest, and pain on movement. Postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) system at 1, 4, 8, 12, 24, 48 and 72 hours. The VAS used will be the 11 point verbal response pain scale with 0 being no pain at all and 10 being the worst possible pain. The patients will be asked to rate their pain levels using this numeric scale. | 1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Nerve Block, Liposomal Bupivacaine