Parasternal Nerve Block in Cardiac Patients
Condition: Coronary Artery Disease; Pain, Postoperative
MeSH terms: Coronary Artery Disease; Pain, Postoperative
Intervention: Exparel; Placebo
Intervention description: Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.
Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.; Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.
Post-surgical pain management will be the same as for the Exparel group.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain management; Anesthetic, local; Nerve blockade; Coronary Artery Bypass Surgery; Analgesics, opioid; Postoperative complications; Bupivacaine

Summary:

      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.
    

Eligibility criteria:

        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.