0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

Study Overview
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Brief Summary
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Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.

Detailed Description
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This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients fit to discharge on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies: Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.

Official Title
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Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Exparel
* Drug: 0.25% bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis Ages 40- 80 years old American Society of Anesthesiologists class I-III Exclusion Criteria: Refusal or absolute medical contraindication to peripheral nerve block refusal or absolute medical contraindication to spinal anesthesia conversion of spinal anesthesia to general anesthesia is obtained inability to cooperate allergy to any drug used in this study daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl) alcohol dependence or use of any illegal drugs within the last month inability to perform the mobilization test and timed up and go (TUG) test pre-operatively

Ages Eligible for Study
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Minimum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivicaine<br>0.25% bupivacaine in patients undergoing total knee arthroplasty | Drug: 0.25% bupivacaine<br>* 0.25% bupivacaine in patients undergoing total knee arthroplasty<br>* Other names: liposomal;|
| Experimental: Bupivicaine + Exparel<br>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty | Drug: Exparel<br>* 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty<br>Drug: 0.25% bupivacaine<br>* 0.25% bupivacaine in patients undergoing total knee arthroplasty<br>* Other names: liposomal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AM-PAC Score to Measure Patients Fitness for Discharge | AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge. | Post-Operation Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption During the First 48 Hours After TKA Surgery | Monitor how much opioid patient consumes | During the first 48 hours after surgery | 
| Pain Scores During 48 Hrs Postoperatively | Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain. | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee arthroplasty, bupivacaine, anesthesia