Status:
COMPLETED
Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery
Lead Sponsor:
Baylor Research Institute
Conditions:
Cardiovascular Surgery
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solu...
Detailed Description
Background: Prolonged and excessive narcotic usage in the postoperative setting has been linked to multiple complications. Use of complimentary pain management techniques such as regional analgesia c...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Undergoing a surgical procedure through mini- or full sternotomy.
Exclusion
- Clinical instability
- Allergic to liposomal bupivacaine solution or any of its ingredients
- Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg).
- BMI \>45
- Pregnant or nursing
- Chronic home opioid usage
- Left Ventricular Ejection Fraction (LVEF) \< 30%
- Low cardiac output requiring mechanical or inotropic support
- End-stage renal disease
- Cirrhosis
Key Trial Info
Start Date :
February 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04333095
Start Date
February 6 2020
End Date
June 26 2021
Last Update
October 22 2025
Active Locations (1)
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1
Baylor Scott & White Heart Hospital - Plano
Plano, Texas, United States, 75093