Trial Outcomes & Findings for Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride (NCT NCT03270514)
NCT ID: NCT03270514
Last Updated: 2021-09-05
Results Overview
Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
Exparel Injectable Product
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Baseline characteristics by cohort
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
65 years
n=7 Participants
|
65.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body Mass Index
|
32 kg/m^2
n=5 Participants
|
31.3 kg/m^2
n=7 Participants
|
31.7 kg/m^2
n=5 Participants
|
|
Diabetes mellitus
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Hypertension
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Congestive heart failure
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tobacco use
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Chronic lung disease
Mild or no disease
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Chronic lung disease
Severe
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Chronic lung disease
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Peripheral vascular disease
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cerebrovascular disease
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Preoperative hospitalization
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Hematocrit
|
40.7 Percentage Hematocrit
n=5 Participants
|
41.8 Percentage Hematocrit
n=7 Participants
|
41.5 Percentage Hematocrit
n=5 Participants
|
|
Serum creatinine
|
1.0 mg/dL
n=5 Participants
|
1.0 mg/dL
n=7 Participants
|
1.0 mg/dL
n=5 Participants
|
|
Total albumin
|
4 g/dL
n=5 Participants
|
4.1 g/dL
n=7 Participants
|
4 g/dL
n=5 Participants
|
|
Total bilirubin
|
0.6 mg/dL
n=5 Participants
|
0.6 mg/dL
n=7 Participants
|
0.6 mg/dL
n=5 Participants
|
|
Last hemoglobin A1C
|
6.2 percentage A1C
n=5 Participants
|
6.0 percentage A1C
n=7 Participants
|
6.1 percentage A1C
n=5 Participants
|
|
Society of thoracic surgeons predicted mortality risk
|
0.009 percentage of mortality risk
n=5 Participants
|
0.007 percentage of mortality risk
n=7 Participants
|
0.008 percentage of mortality risk
n=5 Participants
|
|
Left ventricular ejection fraction
|
57.5 percent ejection fraction
n=5 Participants
|
58 percent ejection fraction
n=7 Participants
|
58 percent ejection fraction
n=5 Participants
|
|
Angiotensin converting enzyme inhibitor/angiotensin receptor blocker use
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Betablockers within 2 weeks preoperatively
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Aspirin within 5 days preoperatively
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Lipid lowering drugs within 24 hours preoperatively
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Procedure
Coronary artery bypass graft
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Procedure
Valve procedure
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Procedure
Combined coronary artery bypass graft & valve procedure
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Duration of cardiopulmonary bypass
|
128 minutes
n=5 Participants
|
134 minutes
n=7 Participants
|
129 minutes
n=5 Participants
|
|
Lowest body temperature on bypass
|
34.2 degrees Celcius
n=5 Participants
|
33.8 degrees Celcius
n=7 Participants
|
34 degrees Celcius
n=5 Participants
|
|
Duration of surgery
|
305 minutes
n=5 Participants
|
335 minutes
n=7 Participants
|
329 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operativelyPostoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Post-operative Pain Intensity
72hrs. at rest
|
4.2862 score on a scale
Interval 0.0 to 10.0
|
4.452 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
4hrs. at rest
|
4.7482 score on a scale
Interval 0.0 to 10.0
|
5.03 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
4hrs. with movement
|
5.75 score on a scale
Interval 0.0 to 10.0
|
6.64 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
8hrs. at rest
|
4.7262 score on a scale
Interval 0.0 to 10.0
|
4.996 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
8hrs. with movement
|
5.74 score on a scale
Interval 0.0 to 10.0
|
6.6 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
12hrs. at rest
|
4.7042 score on a scale
Interval 0.0 to 10.0
|
4.962 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
12hrs. with movement
|
5.73 score on a scale
Interval 0.0 to 10.0
|
6.56 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
16hrs. at rest
|
4.6822 score on a scale
Interval 0.0 to 10.0
|
4.928 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
16hrs. with movement
|
5.72 score on a scale
Interval 0.0 to 10.0
|
6.52 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
20hrs. at rest
|
4.6602 score on a scale
Interval 0.0 to 10.0
|
4.894 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
20hrs. with movement
|
5.71 score on a scale
Interval 0.0 to 10.0
|
6.48 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
24hrs. at rest
|
4.6382 score on a scale
Interval 0.0 to 10.0
|
4.86 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
24hrs. with movement
|
5.7 score on a scale
Interval 0.0 to 10.0
|
6.44 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
32hrs. at rest
|
4.5942 score on a scale
Interval 0.0 to 10.0
|
4.792 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
32hrs. with movement
|
5.68 score on a scale
Interval 0.0 to 10.0
|
6.32 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
40hrs. at rest
|
4.5282 score on a scale
Interval 0.0 to 10.0
|
4.724 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
40hrs. with movement
|
5.66 score on a scale
Interval 0.0 to 10.0
|
6.24 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
48hrs. at rest
|
4.4622 score on a scale
Interval 0.0 to 10.0
|
4.656 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
48hrs. with movement
|
5.64 score on a scale
Interval 0.0 to 10.0
|
6.16 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
60hrs. at rest
|
4.3742 score on a scale
Interval 0.0 to 10.0
|
4.554 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
60hrs. with movement
|
5.61 score on a scale
Interval 0.0 to 10.0
|
6.04 score on a scale
Interval 0.0 to 10.0
|
|
Post-operative Pain Intensity
72hrs. with movement
|
5.58 score on a scale
Interval 0.0 to 10.0
|
5.92 score on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: 0-72 hours post-operative periodAll narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Total Narcotic Consumption
0-8 hours
|
15 oral morphine equivalents in mg
Interval 7.5 to 30.0
|
10 oral morphine equivalents in mg
Interval 0.0 to 19.0
|
|
Total Narcotic Consumption
8-24 hours
|
45 oral morphine equivalents in mg
Interval 30.0 to 60.0
|
34.5 oral morphine equivalents in mg
Interval 15.0 to 52.5
|
|
Total Narcotic Consumption
24-48 hours
|
45 oral morphine equivalents in mg
Interval 10.0 to 75.0
|
45 oral morphine equivalents in mg
Interval 12.0 to 67.5
|
|
Total Narcotic Consumption
48-72 hours
|
15 oral morphine equivalents in mg
Interval 2.5 to 53.0
|
26.5 oral morphine equivalents in mg
Interval 5.0 to 45.0
|
|
Total Narcotic Consumption
0-72 hours
|
139 oral morphine equivalents in mg
Interval 73.0 to 212.0
|
105 oral morphine equivalents in mg
Interval 54.5 to 188.0
|
SECONDARY outcome
Timeframe: From the end of surgery until the patient is extubated up to 72 hours post-operativelyThe time it takes until the patient is extubated post-operatively will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Time to Extubation
|
3.85 hours
Interval 2.65 to 8.17
|
3.47 hours
Interval 2.49 to 9.58
|
SECONDARY outcome
Timeframe: From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*The time it takes until patient ambulates will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Patient Time to Mobilization
|
42 hours
Interval 19.0 to 51.0
|
45 hours
Interval 33.0 to 78.0
|
SECONDARY outcome
Timeframe: From time of end of surgery to time of mobilization up to 72 hours post-operativelyThe time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Patient Time to Out of Bed to Chair
|
16 hours
Interval 11.0 to 19.0
|
16 hours
Interval 8.0 to 20.0
|
SECONDARY outcome
Timeframe: From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital dischargeThe time it takes until the patient is able to/medically cleared to consume food or liquid will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Patient Time to Oral Intake
|
7 hours
Interval 5.0 to 18.0
|
5.6 hours
Interval 4.0 to 18.0
|
SECONDARY outcome
Timeframe: From time of end of surgery to 72 hours post-operatively or until hospital dischargeEpisodes of NIV such as upper airway masks or similar devices will be quantified
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Non-invasive Ventilation (NIV) Requirement
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From time of end of surgery to patient discharge up to one weekInstances of re-intubation will be recorded
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Re-intubation
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From time of end of surgery to 72 hours post-operativelyFrequency of incentive spirometry will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Use of Incentive Spirometry
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From time of end of surgery to 72 hours post-operativelyWhether a patient experiences at least one episode of nausea and emesis will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Post-operative Nausea and Vomiting
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From date of surgery assessed up to 30 day post-operativelyOrgan systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Major Organ Dysfunction
Pneumonia
|
1 Participants
|
0 Participants
|
|
Major Organ Dysfunction
Renal failure / hemodialysis
|
1 Participants
|
1 Participants
|
|
Major Organ Dysfunction
Cardiac arrest
|
0 Participants
|
1 Participants
|
|
Major Organ Dysfunction
Atrial fibrillation
|
7 Participants
|
15 Participants
|
|
Major Organ Dysfunction
No major organ dysfunction
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From date of surgery assessed up to 30 day post-operativelyLength of both hospital and ICU stay will be measured
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Length of Hospital and ICU Stay
Length of ICU stay
|
1.51 days
Interval 1.08 to 2.11
|
1.71 days
Interval 1.11 to 2.97
|
|
Length of Hospital and ICU Stay
Length of postoperative hospital stay
|
7 days
Interval 5.5 to 8.0
|
6 days
Interval 5.0 to 7.3
|
SECONDARY outcome
Timeframe: From end of surgery assessed up to 30 days post-operativelyReadmission to hospital will be noted
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Hospital Readmission
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From end of surgery assessed up to 30 days post-operativelyMortality will be noted at specific timepoints
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Mortality
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessment will be administered at 48 hours post-operativelyPatients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Delirium
No delirium at 48 hours postoperatively
|
18 Participants
|
18 Participants
|
|
Delirium
Delirium at 48 hours postoperatively
|
7 Participants
|
7 Participants
|
|
Delirium
No delirium assessment conducted at 48 hours postoperatively
|
4 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessment will be administered at 72 hours post-operativelyPatients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Delirium
No delirium at 72 hours postoperatively
|
22 Participants
|
21 Participants
|
|
Delirium
Subsyndromal delirium at 72 hours postoperatively
|
4 Participants
|
3 Participants
|
|
Delirium
Delirium at 72 hours postoperatively
|
1 Participants
|
0 Participants
|
|
Delirium
No delirium assessment conducted at 72 hours postoperatively
|
2 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Given at the time of discharge up to 30 days post-operativelyPatient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Patient Satisfaction
|
10 score on a scale
Interval 8.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after surgerySubjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Chronic Pain Assessment
Any pain at 6 months
|
9 Participants
|
14 Participants
|
|
Chronic Pain Assessment
Moderate to severe pain at 6 months
|
3 Participants
|
6 Participants
|
|
Chronic Pain Assessment
No pain at 6 months
|
17 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months after surgerySubjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Chronic Pain Assessment
Any pain at 12 months
|
7 Participants
|
12 Participants
|
|
Chronic Pain Assessment
Moderate to severe pain at 12 months
|
4 Participants
|
6 Participants
|
|
Chronic Pain Assessment
No pain at 12 months
|
18 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured 8, 48, and 72 hours post-operativelyStress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.
Outcome measures
| Measure |
Exparel Injectable Product
n=29 Participants
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 Participants
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Serum Cortisol Levels
8 hours postoperatively
|
30 µg/dL
Interval 23.0 to 40.0
|
36.5 µg/dL
Interval 27.0 to 49.0
|
|
Serum Cortisol Levels
48 hours postoperatively
|
15 µg/dL
Interval 11.0 to 20.0
|
19 µg/dL
Interval 14.0 to 24.0
|
|
Serum Cortisol Levels
72 hours postoperatively
|
16 µg/dL
Interval 11.0 to 18.0
|
17 µg/dL
Interval 13.0 to 22.0
|
Adverse Events
Exparel Injectable Product
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Bupivacaine Hydrochloride
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Exparel Injectable Product
n=29 participants at risk
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 participants at risk
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.9%
2/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.4%
1/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
0.00%
0/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
0.00%
0/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Cardiac disorders
Cardiac Arrest
|
3.4%
1/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arrest
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Cardiac disorders
Hypotension requiring aortic balloon pump
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Vascular disorders
Vasodilatory Shock
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
Other adverse events
| Measure |
Exparel Injectable Product
n=29 participants at risk
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
Bupivacaine Hydrochloride
n=31 participants at risk
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
6.9%
2/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
6.5%
2/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Insufficiency
|
3.4%
1/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
0.00%
0/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Cardiac disorders
Atrial Ectopy
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Blood and lymphatic system disorders
Hypoxia
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
3.2%
1/31 • from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first
|
Additional Information
Kathirvel Subramaniam, MD, MPH, FASE
University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine
Phone: 724-799-5852
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place