Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery

Study Overview
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Brief Summary
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Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery

Detailed Description
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Current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative IV acetaminophen, followed by scheduled oral acetaminophen and supplemental IV and PO narcotics. This practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen. Opioids are the most commonly used medications to control pain early after surgery because of their high potency. However, their undesirable effects and risk of dependence become limitations. The Investigators believe Liposomal Bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. The primary endpoint will be a 20% reduction in opioids use.

Official Title
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Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery

Conditions
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Cardiothoracic Surgery

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: 0.25% Bupivacaine with epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old All open heart surgeries from September 1, 2019 - September 30, 2020 Able to read, comprehend and sign the informed consent form Exclusion Criteria: Pregnancy < 18 years old and prisoners Not able to sign informed consent, including patients with an (LAR) legally authorized representative Patients with chronic pain requiring scheduled narcotic use Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease Recent MI within 7 days of scheduled Cardiac surgery Known allergy to Liposomal Bupivacaine or derivative of Have or is currently involved in a Research Study within 30 days of scheduled surgery

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
Interventional Model Description: Study comparing current standard of therapy using 0.25% bupivacaine with epinepherine at 1cc/kg total dose and the addition of liposomal bupivacaine 266mg/20ml for pain management in cardiac surgery. Patient and Investigator are blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exparel<br>administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine . | Drug: Liposomal bupivacaine<br>* 20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space<br>* Other names: Exparel;Drug: 0.25% Bupivacaine with epinephrine<br>* 0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space<br>|
| Active Comparator: Standard of Therapy<br>administration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose | Drug: 0.25% Bupivacaine with epinephrine<br>* 0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% change in opioids use | Record daily narcotic use | From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Record in 15 minutes intervals the time when the breathing tube is removed | Post operative day of surgery through study completion, an average of 1 year | 
| Time to ICU | Record time in 15 minute intervals the length of time in ICU | Post operative day of surgery through study completion, an average of 1 year | 
| Pain Scores on Post op day 2,3 and 4 | Record pain scores using the Wong - Baker FACES Pain rating scale and /or CPOT Critical Care Pain Observation Tool. Collecting the Scale ratings of 4-10.*Face #4 Hurts a Little, Face#6 Hurts Even More, Face #8 Hurts a Whole Lot Face#10 Hurts Worst. CPOT- Critical Care Pain Observational Tool Documenting Pain Intensity, Pain Location, Pain Radiation and Pain Description. | Post operative day of cardiac surgery through Post operative Day 4 | 
| Total narcotic use on Post op Day 2,3, and 4 | Record daily narcotic use both Oral and Intravenous administration | Day of cardiac surgery to Post op day 4 | 
| Time to Hospital Discharge | Record the number of days(LOS) length of stay in the hospital from post operative surgery to discharge | Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year | 
| Major Adverse Cardiac Effects of Liposomal Bupivacaine | Record Major Adverse Cardiac Effects associated with Liposomal Bupivacaine, Arrythmias, Hypotension > 90/50,AV Block and Cardiac Arrest | Time of peristernal and fifth intercostal infiltration of liposomal bupivacaine through the expected half life associated with liposomal formulation ranging from 23.8 up to 34.1 hours. |