Trial Outcomes & Findings for Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery (NCT NCT04333095)
NCT ID: NCT04333095
Last Updated: 2025-10-22
Results Overview
The amount of opioid medications used will be recorded during the routine postoperative course.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Up to 72 hours post-op
Results posted on
2025-10-22
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine Block
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
Saline Block
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
Full Sternotomy
|
32
|
29
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine Block
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
Saline Block
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Unblinded anesthesiologist unavailable to give block at the time of surgery
|
1
|
4
|
|
Overall Study
Mini Sternotomy
|
4
|
5
|
Baseline Characteristics
Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine Block
n=27 Participants
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy
|
Saline Block
n=25 Participants
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
70 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
History of Tobacco Use
Yes
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
History of Tobacco Use
No
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Chronic lung disease
Yes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Chronic lung disease
No
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Chronic lung disease
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hypertension
Yes
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Hypertension
No
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Hyperlipidemia
Yes
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Hyperlipidemia
No
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Chronic kidney disease
Yes
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Chronic kidney disease
No
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
History of cerebrovascular disease
Yes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
History of cerebrovascular disease
No
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hours post-opThe amount of opioid medications used will be recorded during the routine postoperative course.
Outcome measures
| Measure |
Liposomal Bupivacaine Block
n=27 Participants
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
Saline Block
n=25 Participants
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
|---|---|---|
|
Total Postoperative Opioid Measured in Milligram Morphine Equivalent (MME) at 72 Hours
|
29.4 Milligram Morphine Equivalent (MME)
Standard Deviation 16.3
|
25.8 Milligram Morphine Equivalent (MME)
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: During surgery, up to 7 hoursOutcome measures
| Measure |
Liposomal Bupivacaine Block
n=27 Participants
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Liposomal bupivacaine: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
Saline Block
n=25 Participants
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Normal Saline Flush, 0.9% Injectable Solution\_#1: Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy. We couldn't enroll sufficient mini sternotomies to infer anything statistically so our analysis concentrated on full sterntomies.
|
|---|---|---|
|
Intraoperative Opioid Usage Measured in Milligram Morphine Equivalent (MME)
|
114.9 Milligram Morphine Equivalent (MME)
Standard Deviation 148
|
124.8 Milligram Morphine Equivalent (MME)
Standard Deviation 22.5
|
Adverse Events
Liposomal Bupivacaine Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Hale, Project Manager
Baylor Scott & White Research Institute
Phone: 469-814-4845
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place