Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01826851
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01826851
Study Brief:
Protocol Section:
NCT01826851