Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty

Study Overview
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Brief Summary
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Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.

Detailed Description
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Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.

Official Title
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Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.

Conditions
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Pain

Intervention / Treatment
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* Drug: Peripheral Nerve Blockade
* Behavioral: 10 meter walk test on post-operative day 1
* Other: In person and over the phone questionnaire
* Device: Force transduction of quadriceps strength


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is scheduled for elective unilateral TKA; The subject is ≥ 18 years and ≤ 80 years; The subject's weight is between 65-130 kg; The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural); The patient agrees to receive an adductor canal block; American Society of Anesthesiologists class 1-3. Exclusion Criteria: Subject is < 18 years of age or >80 years of age; Subject is non-English speaking; Subject is known or believed to be pregnant; Subject is a prisoner; Subject has impaired decision-making capacity per discretion of the Investigator; Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration; Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate; Significant pre-existing neuropathy on the operative limb; Significant renal, cardiac or hepatic disease per discretion of the investigator; American Society of Anesthesiologists class 4-5; Known hypersensitivity and/or allergies to local anesthetics; Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine group<br>20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) | Drug: Peripheral Nerve Blockade<br>* Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization<br>Behavioral: 10 meter walk test on post-operative day 1<br>* Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist<br>Other: In person and over the phone questionnaire<br>* Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores<br>Device: Force transduction of quadriceps strength<br>* Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1<br>|
| Active Comparator: Standard bupivacaine group<br>20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) | Drug: Peripheral Nerve Blockade<br>* Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization<br>Behavioral: 10 meter walk test on post-operative day 1<br>* Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist<br>Other: In person and over the phone questionnaire<br>* Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores<br>Device: Force transduction of quadriceps strength<br>* Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Meter Walk Test | Time to comfortably walk 10 meters as deemed safe by physical therapy | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain. | Day 0, Day 1, Day 2, Day 3 | 
| Opioid Consumption in Morphine Equivalents | Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared. | Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3 | 
| Number of Participants Who Experienced Nausea | Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview | Day 0, Day 1, Day 2, Day 3 | 
| Quadriceps Strength | Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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10 meter walk test, Opioid consumption