Cardiothoracic Surgery
Conditions
Brief summary
Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery
Detailed description
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.
Interventions
DRUGLiposomal bupivacaine
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
Sponsors
Florida Heart and Lung Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be randomized per study coordinator. SOC includes 0.25%bupivacaine with epinephrine at 1cc/kg total dose and the treatment arm will include liposomal bupivacaine 266mg/20ml added to usual dose.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20% change in opioids use | From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year. | Record daily narcotic use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ICU | Post operative day of surgery through study completion, an average of 1 year | Record time in 15 minute intervals the length of time in ICU |
| Pain Scores on Post op day 2,3 and 4 | Post operative day of cardiac surgery through Post operative Day 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 to extubation | Post operative day of surgery through study completion, an average of 1 year | Record in 15 minutes intervals the time when the breathing tube is removed |
| Time to Hospital Discharge | Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year | Record the number of days(LOS) length of stay in the hospital from post operative surgery to discharge |
| Major Adverse Cardiac Effects of Liposomal Bupivacaine | 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. | Record Major Adverse Cardiac Effects associated with Liposomal Bupivacaine, Arrythmias, Hypotension \> 90/50,AV Block and Cardiac Arrest |
| Total narcotic use on Post op Day 2,3, and 4 | Day of cardiac surgery to Post op day 4 | Record daily narcotic use both Oral and Intravenous administration |
Countries
United States
Outcome results
None listed