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

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

Study Overview

• Status: Unknown
• Conditions: Cardiothoracic Surgery
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: 0.25% Bupivacaine with epinephrine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • Florida Heart and Lung Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Florida Heart and Lung Institute
• Investigators: Principal Investigator: Charles T Klodell, MD, Florida Heart and Lung Institute, HCA Physician Services

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: IIT#2018-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No