Parasternal Nerve Block in Cardiac Patients

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter A Knight
• Treatments: Bupivacaine

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.