Parasternal Nerve Block in Cardiac Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Post-Surgical Pain, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | March 2013 |
| End Date: | June 2017 |
Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients: A Randomized, Controlled Trial of Extended-release Liposomal Bupivacaine (Exparel) Versus Placebo
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.
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.
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.
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Peter A Knight, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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