Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

Launched by BAYLOR RESEARCH INSTITUTE · Apr 1, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a pain management medication called liposomal bupivacaine for patients undergoing heart surgery that requires cutting through the breastbone, a procedure known as a sternotomy. The goal is to see if giving this medication before the incision helps reduce pain after surgery, compared to using saline (a simple saltwater solution). By aiming to lessen pain and possibly decrease the amount of other pain medications needed, the researchers hope to improve the overall recovery experience for patients.

To participate in the study, you need to be at least 18 years old and scheduled for a sternotomy. However, some people won't be eligible, such as those with specific health conditions or who are pregnant. If you join the study, you'll receive the study medication or saline before the surgery and be monitored for about 72 hours or until you leave the hospital. This trial is currently looking for participants, and your involvement could help improve pain management for future heart surgery patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than 18 years
• • 2. Undergoing a surgical procedure through mini- or full sternotomy.
• Exclusion Criteria:
• • 1. Clinical instability
• • 2. Allergic to liposomal bupivacaine solution or any of its ingredients
• • 3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg).
• • 4. BMI \>45
• • 5. Pregnant or nursing
• • 6. Chronic home opioid usage
• • 7. Left Ventricular Ejection Fraction (LVEF) \< 30%
• • 8. Low cardiac output requiring mechanical or inotropic support
• • 9. End-stage renal disease
• • 10. Cirrhosis