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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiothoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Exparel

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

.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space

0.25% Bupivacaine with epinephrine

Intervention Type DRUG

0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Standard of Therapy

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

Group Type ACTIVE_COMPARATOR

0.25% Bupivacaine with epinephrine

Intervention Type DRUG

0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Interventions

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Liposomal bupivacaine

20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space

Intervention Type DRUG

0.25% Bupivacaine with epinephrine

0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No