Trial Outcomes & Findings for Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery (NCT NCT03482973)
NCT ID: NCT03482973
Last Updated: 2020-08-03
Results Overview
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
48 hours
Results posted on
2020-08-03
Participant Flow
80 Participants signed consent and none of the participants was withdrawn prior to randomization.
Participant milestones
| Measure |
Interventional Bupivacaine
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.78 years
STANDARD_DEVIATION 8.73 • n=99 Participants
|
65.70 years
STANDARD_DEVIATION 9.86 • n=107 Participants
|
65.73 years
STANDARD_DEVIATION 9.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Weight
|
86.53 Kg
STANDARD_DEVIATION 18.44 • n=99 Participants
|
85.55 Kg
STANDARD_DEVIATION 15.10 • n=107 Participants
|
86.04 Kg
STANDARD_DEVIATION 16.75 • n=206 Participants
|
|
Height
|
173.73 cm
STANDARD_DEVIATION 12.08 • n=99 Participants
|
172.02 cm
STANDARD_DEVIATION 9.96 • n=107 Participants
|
172.88 cm
STANDARD_DEVIATION 11.03 • n=206 Participants
|
|
Body Mass Index (BMI)
|
28.57 Kg/m^2
STANDARD_DEVIATION 5.10 • n=99 Participants
|
28.92 Kg/m^2
STANDARD_DEVIATION 4.84 • n=107 Participants
|
28.74 Kg/m^2
STANDARD_DEVIATION 4.94 • n=206 Participants
|
|
Preoperative comorbidities
None
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Preoperative comorbidities
Peripheral vascular disease
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Preoperative comorbidities
Connective tissue disease
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Ulcer disease
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Preoperative comorbidities
Mild Liver disease
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Diabetes without complications
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Preoperative comorbidities
Diabetes with end organ damage
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Preoperative comorbidities
Hemiplegia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Moderate or severe renal disease
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Preoperative comorbidities
Solid tumor (Non-metastatic)
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Preoperative comorbidities
Solid tumor (Metastatic)
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Preoperative comorbidities
Acquired immunodeficiency syndrome (AIDS)
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Preoperative comorbidities
Chronic pain
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Preoperative comorbidities
Hypertension
|
31 participants
n=99 Participants
|
27 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Preoperative comorbidities
Hyperlipidemia
|
29 participants
n=99 Participants
|
23 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Preoperative comorbidities
Leukemia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Lymphoma or multiple myeloma
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Moderate or severe liver disease
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Preoperative comorbidities
Congestive heart failure
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Preoperative comorbidities
Arrhythmia
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Preoperative comorbidities
Coagulopathy
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Preoperative comorbidities
Hypercoagulability
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Preoperative comorbidities
Obesity
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Preoperative comorbidities
Chronic obstructive pulmonary disease(COPD)/Asthma
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Surgical characteristics
Isolated Coronary artery bypass grafting (CABG)
|
22 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Surgical characteristics
CABG surgery + additional surgery
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Surgical characteristics
Valve surgery
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Surgical characteristics
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Past surgical history
None
|
25 participants
n=99 Participants
|
23 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Past surgical history
Cardiac surgery
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Past surgical history
Coronary artery stenting
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Past surgical history
Vascular surgery
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Past surgical history
Open abdominal surgery
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursTotal opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Outcome measures
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Opioid Consumption
|
40.8 Milligram Morphine Equivalents (MME)
Standard Deviation 22.4
|
49.1 Milligram Morphine Equivalents (MME)
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: At 6-8 hourly intervals every day until discharge or 4 daysPatient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.
Outcome measures
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Pain Scores
|
4.8 score on a scale
Standard Deviation 2.7
|
5.1 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 daysTotal duration of stay in ICU for the index admission
Outcome measures
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
ICU Length of Stay
|
1.2 days
Interval 1.0 to 2.8
|
1.7 days
Interval 1.0 to 3.2
|
SECONDARY outcome
Timeframe: Measured in days admitted in the hospital, an average of 5 daysTheir stay in the hospital for the index admission
Outcome measures
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Hospital Length of Stay
|
8 days
Interval 7.0 to 11.0
|
7.5 days
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: 7 days post-op on an averageThis includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
Outcome measures
| Measure |
Interventional Bupivacaine
n=40 Participants
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 Participants
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Number of Participants With Complications
|
0 Participants
|
0 Participants
|
Adverse Events
Interventional Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interventional Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Interventional Bupivacaine
n=40 participants at risk
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
|
Interventional Placebo
n=40 participants at risk
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
|
|---|---|---|
|
Infections and infestations
Abdominal Sepsis
|
0.00%
0/40 • All adverse events will be assessed daily during the hospital stay for a maximum of 4 postoperative days
Anticipated and unanticipated deaths, serious adverse events, and other adverse events due to any cause, whether related or unrelated to study procedures.
|
2.5%
1/40 • Number of events 1 • All adverse events will be assessed daily during the hospital stay for a maximum of 4 postoperative days
Anticipated and unanticipated deaths, serious adverse events, and other adverse events due to any cause, whether related or unrelated to study procedures.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Balachundhar Subramaniam
Beth Israel Deaconess Medical Center
Phone: 6176320706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place