Clinical trial NCT04065919: Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
Official title: Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiothoracic Surgery
Lead sponsor: Florida Heart and Lung Institute
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 20% change in opioids use
timeFrame: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.
Secondary outcomes:
measure: Time to extubation
timeFrame: Post operative day of surgery through study completion, an average of 1 year
measure: Time to ICU
timeFrame: Post operative day of surgery through study completion, an average of 1 year
measure: Pain Scores on Post op day 2,3 and 4
timeFrame: Post operative day of cardiac surgery through Post operative Day 4
measure: Total narcotic use on Post op Day 2,3, and 4
timeFrame: Day of cardiac surgery to Post op day 4
measure: Time to Hospital Discharge
timeFrame: Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year
measure: Major Adverse Cardiac Effects of Liposomal Bupivacaine
timeFrame: 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.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Florida Heart and Lung Institute
state: Florida
Study officials:
affiliation: Florida Heart and Lung Institute, HCA Physician Services
name: Charles T Klodell, MD
role: PRINCIPAL_INVESTIGATOR
References: