Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space
0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space
Florida Heart and Lung Institute
Gainesville, Florida, United States
20% change in opioids use
Record daily narcotic use
Time frame: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.
Time to extubation
Record in 15 minutes intervals the time when the breathing tube is removed
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year
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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 frame: 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.