Parasternal Nerve Block in Cardiac Patients

Phase 2

Completed

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 to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.

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) 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.9% Normal saline, single-dose injection.
Exparel	Exparel	266 mg Exparel, single-dose injection.

Primary Outcome Measures

Name	Time	Method
Median Cumulative Morphine Equivalent	Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.	The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.
Median Pain Levels	Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.	The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.

Secondary Outcome Measures

Name	Time	Method
Time to First Bowel Movement (Days)	35 days	Time to first bowel movement following surgery.
Hospital Length of Stay (Days)	25 days	Duration of time spent in the hospital following surgery.
Time to Extubation (Hours)	77 hours	Time to remove endotracheal tube following surgery.
ICU Length of Stay (Hours)	135 hours	Duration of time spent in the intensive care unit postoperatively.
Time to Return to Work or Daily Activities	36 days	Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.

Locations (1): University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States