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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure. Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU.
Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure. Post-surgical pain management will be the same as for the Exparel group.
University of Rochester Medical Center
Rochester, New York, United States
Median Cumulative Morphine Equivalent
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.
Time frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
Median Pain Levels
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.
Time frame: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.
Time to Extubation (Hours)
Time to remove endotracheal tube following surgery.
Time frame: 77 hours
ICU Length of Stay (Hours)
Duration of time spent in the intensive care unit postoperatively.
Time frame: 135 hours
Time to First Bowel Movement (Days)
Time to first bowel movement following surgery.
Time frame: 35 days
Hospital Length of Stay (Days)
Duration of time spent in the hospital following surgery.
Time frame: 25 days
Time to Return to Work or Daily Activities
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.
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Time frame: 36 days