Coronary Artery Disease Clinical Trial
Official title:
Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.
This is a Phase 2, single-institution, randomized, double-blind, parallel-group,
placebo-controlled trial of patients undergoing a median sternotomy for primary
cardiopulmonary bypass grafting (CABG) surgery.
78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a
single-dose, parasternal nerve block with either 266 mg Exparel or placebo (0.9% normal
saline solution). The nerve blocks will be performed under direct visualization at the end of
surgery, just prior to sternal closure.
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