Parasternal Nerve Block in Cardiac Patients
Parasternal Nerve Block in Cardiac Patients
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.
Inclusion Criteria:

 -  ≥ 18 years old

 -  non-emergent coronary artery bypass grafting surgery (on and off pump)

 -  median sternotomy

 Exclusion Criteria:

 -  Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve
 repair/replacement, aortic root replacements).

 -  Redo sternotomy.

 -  < 50 kg (Exparel® is currently only approved in patients > 50 kg).

 -  Pregnant or nursing

 -  History of alcohol, narcotic or illicit drug abuse

 -  Participation in another study evaluating investigational medications within the past
 30 days

 -  Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose
 steroids.

 -  Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic
 analgesics.

 -  Pre-operative mild liver insufficiency as defined by liver function tests [(i.e.
 alanine aminotransferase (ALT), aspartate aminotransferase (AST)] ≥ 1.5 times the
 upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total
 bilirubin: 0-1.2 mg/dL)

 -  Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)

 -  Allergy to amide-type anesthetics

 -  Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or
 intra-aortic balloon pump support, left ventricular ejection fraction < 30% at time of
 pre-operative screening/evaluation.

 -  Unable to provide informed consent or unable to understand how to use pain rating
 scales.

 -  Inability to understand or operate the patient-controlled analgesia (PCA) machine.