Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery
Completed · Phase 4
Conditions studied: Cardiovascular Surgery, Pain, Postoperative, Block
In brief
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.
Key facts
- Study ID
- NCT04333095
- Run by
- Baylor Research Institute
- People needed
- 70
- Starts
- 2020-02-06
- Expected to finish
- 2021-06-26
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than 18 years
- Undergoing a surgical procedure through mini- or full sternotomy.
You may not qualify if…
- 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
Where it is running
- Baylor Scott & White Heart Hospital - Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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