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

Cardiothoracic Surgery Clinical Trial

— EXPAREL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04065919
• Other study ID #: IIT#2018-137
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2020
• Source: Florida Heart and Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiothoracic Surgery

Intervention

Drug:
• Liposomal bupivacaine
20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space
• 0.25% Bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Locations

Country	Name	City	State
United States	Florida Heart and Lung Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Heart and Lung Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.