NCT04065919

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Florida Heart and Lung Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiothoracic Surgery

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space
DRUG	0.25% Bupivacaine with epinephrine	0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-30
• Completion: 2020-11-30
• First posted: 2019-08-22
• Last updated: 2020-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study