Status:
UNKNOWN
Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
Lead Sponsor:
Florida Heart and Lung Institute
Conditions:
Cardiothoracic Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ope...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04065919
Start Date
October 1 2019
End Date
November 30 2020
Last Update
February 6 2020
Active Locations (1)
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1
Florida Heart and Lung Institute
Gainesville, Florida, United States, 32605