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

Florida Heart and Lung Institute

Status and phase: Unknown; Phase 4

Conditions: Cardiothoracic Surgery

Treatments: Drug: 0.25% Bupivacaine with epinephrine; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04065919

IIT#2018-137

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Exparel

Active Comparator group

Description:

administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine .

Treatment:

Drug: Liposomal bupivacaine

Drug: 0.25% Bupivacaine with epinephrine

Standard of Therapy

Active Comparator group

Description:

administration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose

Treatment:

Drug: 0.25% Bupivacaine with epinephrine