Status:
COMPLETED
Parasternal Nerve Block in Cardiac Patients
Lead Sponsor:
Peter A Knight
Conditions:
Coronary Artery Disease
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- ≥ 18 years old
- non-emergent coronary artery bypass grafting surgery (on and off pump)
- median sternotomy
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01826851
Start Date
March 1 2013
End Date
June 1 2017
Last Update
August 1 2018
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642