Overview

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

Status:
Recruiting

Trial end date:
2021-06-01

Target enrollment:
0

Participant gender:
All

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 solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Baylor Research Institute

Treatments:

Bupivacaine
Pharmaceutical Solutions

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