Trial Outcomes & Findings for Parasternal Nerve Block in Cardiac Patients (NCT NCT01826851)

Last Updated: 2018-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.

Results posted on

2018-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel 266 mg Exparel, single-dose injection. Exparel: 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.	Placebo 0.9% Normal saline, single-dose injection. Placebo: 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.
Overall Study STARTED	38	41
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parasternal Nerve Block in Cardiac Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Total n=79 Participants Total of all reporting groups
Age, Categorical Age Distribution · <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Age Distribution · Between 18 and 65 years	16 Participants n=93 Participants	24 Participants n=4 Participants	40 Participants n=27 Participants
Age, Categorical Age Distribution · >=65 years	22 Participants n=93 Participants	17 Participants n=4 Participants	39 Participants n=27 Participants
Age, Continuous	66 years STANDARD_DEVIATION 7.7 • n=93 Participants	64 years STANDARD_DEVIATION 8.6 • n=4 Participants	65 years STANDARD_DEVIATION 8.19 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	36 Participants n=4 Participants	67 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	38 Participants n=93 Participants	40 Participants n=4 Participants	78 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	38 Participants n=93 Participants	41 Participants n=4 Participants	79 Participants n=27 Participants
BMI	31 kg/m^2 STANDARD_DEVIATION 4.8 • n=93 Participants	30.4 kg/m^2 STANDARD_DEVIATION 4.7 • n=4 Participants	30.7 kg/m^2 STANDARD_DEVIATION 4.7 • n=27 Participants

PRIMARY outcome

Timeframe: Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Median Cumulative Morphine Equivalent 1 hour post injection	2.5 Morphine Equivalents Interval 0.0 to 1.25	0 Morphine Equivalents Interval 0.0 to 0.0
Median Cumulative Morphine Equivalent 2 hours post injection	5 Morphine Equivalents Interval 0.0 to 5.0	0 Morphine Equivalents Interval 0.0 to 5.0
Median Cumulative Morphine Equivalent 4 hours post injection	8.4 Morphine Equivalents Interval 0.0 to 5.0	5 Morphine Equivalents Interval 0.0 to 5.0
Median Cumulative Morphine Equivalent 8 hours post injection	6 Morphine Equivalents Interval 3.5 to 15.0	5 Morphine Equivalents Interval 0.0 to 9.87
Median Cumulative Morphine Equivalent 12 hours post injection	16 Morphine Equivalents Interval 2.0 to 12.0	13 Morphine Equivalents Interval 1.0 to 11.35
Median Cumulative Morphine Equivalent 24 hours post injection	18 Morphine Equivalents Interval 10.75 to 29.0	11.5 Morphine Equivalents Interval 7.0 to 22.15
Median Cumulative Morphine Equivalent 36 hours post injection	15 Morphine Equivalents Interval 9.0 to 42.0	8.5 Morphine Equivalents Interval 3.06 to 25.37
Median Cumulative Morphine Equivalent 48 hours post injection	3.33 Morphine Equivalents Interval 7.5 to 21.25	4.167 Morphine Equivalents Interval 2.12 to 26.47
Median Cumulative Morphine Equivalent 60 hours post injection	3.33 Morphine Equivalents Interval 1.67 to 8.3	4.167 Morphine Equivalents Interval 0.46 to 6.67
Median Cumulative Morphine Equivalent 72 hours post injection	3.33 Morphine Equivalents Interval 0.0 to 6.67	2.5 Morphine Equivalents Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Median Pain Levels 1 hour post injection	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.0
Median Pain Levels 2 hours post injection	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 0.0
Median Pain Levels 4 hours post injection	0 units on a scale Interval 0.0 to 3.25	0 units on a scale Interval 0.0 to 1.0
Median Pain Levels 8 hours post injection	2 units on a scale Interval 0.0 to 5.0	0 units on a scale Interval 0.0 to 2.75
Median Pain Levels 12 hours post injection	2 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 3.75
Median Pain Levels 24 hours post injection	4 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 4.0
Median Pain Levels 36 hours post injection	2 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 4.0
Median Pain Levels 48 hours post injection	2 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 3.75
Median Pain Levels 60 hours post injection	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0
Median Pain Levels 72 hours post injection	0 units on a scale Interval 0.0 to 3.0	1 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 77 hours

Time to remove endotracheal tube following surgery.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Time to Extubation (Hours)	6.4 Hours Interval 4.3 to 10.9	6.8 Hours Interval 4.2 to 9.6

SECONDARY outcome

Timeframe: 135 hours

Duration of time spent in the intensive care unit postoperatively.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
ICU Length of Stay (Hours)	22.8 Hours Interval 19.0 to 42.0	25 Hours Interval 19.0 to 47.0

SECONDARY outcome

Timeframe: 35 days

Population: Data was not collected on 3 participants in the Exparel arm and 1 participant in the Placebo arm.

Time to first bowel movement following surgery.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=35 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Time to First Bowel Movement (Days)	2 Days Interval 2.0 to 3.0	2 Days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 25 days

Duration of time spent in the hospital following surgery.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=38 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Hospital Length of Stay (Days)	5 Days Interval 4.0 to 6.0	5 Days Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: 36 days

Population: Data was not collected on 15 participants in the Exparel arm and 17 participant in the Placebo arm.

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.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants 0.9% Normal saline, single-dose injection. Placebo: 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.	Exparel n=23 Participants 266 mg Exparel, single-dose injection. Exparel: 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.
Time to Return to Work or Daily Activities	21.3 Days Standard Deviation 7.7	21.8 Days Standard Deviation 6.9

Adverse Events

Exparel

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Peter A. Knight, MD

URochester

Phone: (585) 275-6340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Exparel n=38 participants at risk 266 mg Exparel, single-dose injection. Exparel: 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.	Placebo n=41 participants at risk 0.9% Normal saline, single-dose injection. Placebo: 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.
General disorders Suspected bupivacaine toxicity	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Myocardial infarction	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Transient ischemic attack	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Cerebral vascular accident with permanent deficits	2.6% 1/38 • Number of events 1 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	4.9% 2/41 • Number of events 2 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Infections and infestations Sepsis	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Infections and infestations Mediastinitis	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Surgical and medical procedures Sternal wound dehiscence	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Surgical and medical procedures Reoperation due to graft failure	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Surgical and medical procedures Reoperation for bleeding	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Renal and urinary disorders Renal failure requiring hemodialysis	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Surgical and medical procedures Phrenic nerve Injury	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Readmission to ICU	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Vascular disorders Deep venous thrombosis	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Vascular disorders Pulmonary embolism	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders New onset SVT or ventricular tachycardia	7.9% 3/38 • Number of events 3 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	14.6% 6/41 • Number of events 6 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Heart Failure	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Coma	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Encephalopathy	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Vascular disorders Acute limb ischemia	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Multiorgan failure	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Vascular disorders Aortic dissection	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders New onset ventricular fibrillation	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	4.9% 2/41 • Number of events 2 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.

Measure	Exparel n=38 participants at risk 266 mg Exparel, single-dose injection. Exparel: 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.	Placebo n=41 participants at risk 0.9% Normal saline, single-dose injection. Placebo: 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.
Nervous system disorders Somnolence	31.6% 12/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	29.3% 12/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Tinnitis	15.8% 6/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	7.3% 3/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Tremors	5.3% 2/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Atrial Fibrillation	31.6% 12/38 • Number of events 12 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	31.7% 13/41 • Number of events 13 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Bradycardia	15.8% 6/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	9.8% 4/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Bundle Branch Block	23.7% 9/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	19.5% 8/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders First Degree AV Block	13.2% 5/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	17.1% 7/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Premature Atrial Contraction	5.3% 2/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Palpitations	18.4% 7/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	12.2% 5/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Prolonged QT Interval	21.1% 8/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	12.2% 5/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Premature Ventricular Contraction	28.9% 11/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	26.8% 11/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders ST Changes	5.3% 2/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	14.6% 6/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Cardiac disorders Sinus Tachycardia	23.7% 9/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	14.6% 6/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Gastrointestinal disorders Constipation	42.1% 16/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	48.8% 20/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Gastrointestinal disorders Diarrhea	18.4% 7/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	22.0% 9/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Gastrointestinal disorders Nausea	63.2% 24/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	43.9% 18/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Gastrointestinal disorders Vomiting	23.7% 9/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Anxiety	23.7% 9/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	39.0% 16/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Blurred Vision	7.9% 3/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Chills	7.9% 3/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	7.3% 3/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Diaphoresis	36.8% 14/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	34.1% 14/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Dizziness/Light headedness	47.4% 18/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	53.7% 22/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Fever	5.3% 2/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	14.6% 6/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Itching	7.9% 3/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	0.00% 0/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Metallic Taste in Mouth	13.2% 5/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	17.1% 7/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
General disorders Restlessness	31.6% 12/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	36.6% 15/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Musculoskeletal and connective tissue disorders Generalized Weakness	44.7% 17/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	43.9% 18/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Headache	10.5% 4/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	17.1% 7/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Miosis	0.00% 0/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	7.3% 3/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.
Nervous system disorders Parasthesias	13.2% 5/38 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.	31.7% 13/41 • Adverse event data were collected at throughout a 72 hour post intercostal nerve block at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours. Adverse event data was also collected at the time of follow-up, which occurred at 3-4 weeks post-operatively.