Trial Outcomes & Findings for Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery (NCT NCT04908449)
NCT ID: NCT04908449
Last Updated: 2025-11-17
Results Overview
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
24 hours after extubation
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Rectus Sheath Block With PIFB (Experimental Arm)
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Placebo Arm)
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Rectus Sheath Block With PIFB (Experimental Arm)
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Placebo Arm)
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Overall Study
Patient with major surgical bleeding unerlated to block
|
0
|
1
|
|
Overall Study
Patient required postop RVAD, unrelated to block
|
0
|
1
|
Baseline Characteristics
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Rectus Sheath Block With Pectointercostal Fascial Plane Block (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With Pectointercostal Fascial Plane Block (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.51 • n=39 Participants
|
67.3 years
STANDARD_DEVIATION 8.79 • n=29 Participants
|
67.42 years
STANDARD_DEVIATION 9.08 • n=60 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
9 Participants
n=29 Participants
|
17 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
21 Participants
n=29 Participants
|
43 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=39 Participants
|
30 Participants
n=29 Participants
|
60 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=39 Participants
|
30 participants
n=29 Participants
|
60 participants
n=60 Participants
|
|
Body Mass Index
|
28.9 kg/m2
STANDARD_DEVIATION 4.31 • n=39 Participants
|
30.8 kg/m2
STANDARD_DEVIATION 6.17 • n=29 Participants
|
29.82 kg/m2
STANDARD_DEVIATION 5.36 • n=60 Participants
|
|
Hypertension diagnosis
|
20 Participants
n=39 Participants
|
21 Participants
n=29 Participants
|
41 Participants
n=60 Participants
|
|
Diabetes diagnosis
|
8 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
15 Participants
n=60 Participants
|
|
Coronary artery disease diagnosis
|
23 Participants
n=39 Participants
|
25 Participants
n=29 Participants
|
48 Participants
n=60 Participants
|
|
Peripheral Vascular Disease diagnosis
|
3 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Neuropathy diagnosis
|
2 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Anxiety diagnosis
|
2 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
7 Participants
n=60 Participants
|
|
Depression diagnosis
|
4 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
History of Cerebral Vascular Accident
|
3 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=60 Participants
|
|
Chronic Kidney Disease/End Stage Renal Disease diagnosis
|
5 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
Chronic Obstructive Pulmonary Disease diagnosis
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Coronary Artery Bypass Graft Surgery
|
18 Participants
n=39 Participants
|
20 Participants
n=29 Participants
|
38 Participants
n=60 Participants
|
|
Coronary Artery Bypass Graft with single valve
|
3 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
|
Single valve case
|
9 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
16 Participants
n=60 Participants
|
|
Aortic crossclamp time (hours)
|
1.47 hours
STANDARD_DEVIATION .53 • n=39 Participants
|
1.32 hours
STANDARD_DEVIATION 0.59 • n=29 Participants
|
1.38 hours
STANDARD_DEVIATION .57 • n=60 Participants
|
|
Cardiopulmonary bypass time (hours)
|
1.85 hours
STANDARD_DEVIATION .62 • n=39 Participants
|
1.78 hours
STANDARD_DEVIATION .73 • n=29 Participants
|
1.78 hours
STANDARD_DEVIATION .68 • n=60 Participants
|
|
Total surgical time (hours)
|
4.88 hours
STANDARD_DEVIATION 1.15 • n=39 Participants
|
4.6 hours
STANDARD_DEVIATION 1.3 • n=29 Participants
|
4.73 hours
STANDARD_DEVIATION 1.21 • n=60 Participants
|
|
Intraoperative oral morphine equivalents (mg)
|
297.44 mg
STANDARD_DEVIATION 65.13 • n=39 Participants
|
276.64 mg
STANDARD_DEVIATION 102.9 • n=29 Participants
|
287.04 mg
STANDARD_DEVIATION 86.05 • n=60 Participants
|
PRIMARY outcome
Timeframe: 24 hours after extubationMeasured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Pain Scores at Rest Within the First 24 Hours After Extubation
|
102 Numeric rating score * hours.
Interval 65.0 to 120.0
|
79.25 Numeric rating score * hours.
Interval 0.0 to 117.0
|
PRIMARY outcome
Timeframe: 24 hours after extubationMeasured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation
|
144 Numeric rating score * hours.
Interval 90.0 to 160.0
|
141.5 Numeric rating score * hours.
Interval 97.0 to 159.5
|
PRIMARY outcome
Timeframe: 24 hours post-operativelyTotal cumulative opioid consumption at 24 hours
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Total Cumulative Opioid Consumption
|
58.75 Oral morphine equivalents (mg)
Interval 42.5 to 91.5
|
55.25 Oral morphine equivalents (mg)
Interval 42.5 to 97.5
|
PRIMARY outcome
Timeframe: 48 hours post-operativelyTotal cumulative opioid consumption at 48 hours
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Total Cumulative Opioid Consumption
|
95 Oral morphine equivalents (mg)
Interval 55.0 to 130.25
|
96.75 Oral morphine equivalents (mg)
Interval 57.5 to 145.0
|
SECONDARY outcome
Timeframe: ICU arrival until extubationTime from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation).
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Time From ICU Arrival to Liberation From Mechanical Ventilation
|
3.87 hours
Interval 2.63 to 4.8
|
3.87 hours
Interval 2.08 to 4.82
|
SECONDARY outcome
Timeframe: 1 hour post-extubationPopulation: 7 total patients did not have IS completed at 1 hour by ICU nursing due to either need for bipap/unknown reason.
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=27 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=26 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Vital Capacity Change From Baseline on Incentive Spirometry
|
.24 Percent of baseline IS
Interval 0.18 to 0.34
|
0.25 Percent of baseline IS
Interval 0.17 to 0.29
|
SECONDARY outcome
Timeframe: 3 hours post-extubationVital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Vital Capacity Change From Baseline on Incentive Spirometry
|
.27 Percent of baseline IS
Interval 0.22 to 0.38
|
.26 Percent of baseline IS
Interval 0.22 to 0.36
|
SECONDARY outcome
Timeframe: 12 hours post-extubationPopulation: 3 total patients did not have IS completed at 12 hours by ICU nursing for unknown reasons
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=29 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=28 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Vital Capacity Change From Baseline on Incentive Spirometry
|
.33 Percent of baseline IS
Interval 0.28 to 0.48
|
.28 Percent of baseline IS
Interval 0.21 to 0.37
|
SECONDARY outcome
Timeframe: 24 hours post-extubationPopulation: 7 total patients did not have IS completed at 24 hours by ICU nursing due to unknown reasons.
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=27 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=26 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Vital Capacity Change From Baseline on Incentive Spirometry
|
.30 Percent of baseline IS
Interval 0.26 to 0.45
|
.32 Percent of baseline IS
Interval 0.26 to 0.45
|
SECONDARY outcome
Timeframe: 24 hours after extubationQoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
QoR-15 (Quality of Recovery) Score
|
79.5 score on a scale
Interval 63.0 to 94.0
|
83 score on a scale
Interval 70.0 to 106.0
|
SECONDARY outcome
Timeframe: Time from anesthesia stop to transfer out of ICU, typically 24 hoursICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
ICU Length of Stay
|
25.77 Hours
Interval 22.28 to 45.22
|
20.69 Hours
Interval 17.63 to 37.23
|
SECONDARY outcome
Timeframe: Time from anesthesia stop to hospital discharge, typically one weekHospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.
Outcome measures
| Measure |
Rectus Sheath Block With PIFB (Placebo Arm)
n=30 Participants
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 Participants
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Hospital Length of Stay
|
97.31 Hours
Interval 93.71 to 120.78
|
97.21 Hours
Interval 89.16 to 135.89
|
Adverse Events
Rectus Sheath Block With PIFB (Experimental Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rectus Sheath Block With PIFB (Placebo Arm)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rectus Sheath Block With PIFB (Experimental Arm)
n=30 participants at risk
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
Rectus Sheath Block With PIFB (Placebo Arm)
n=32 participants at risk
PIFB with local anesthetic with RSB placebo (saline)
Rectus sheath block with bupivacaine: Rectus sheath block with local anesthetic versus sham block with saline
|
|---|---|---|
|
Cardiac disorders
Acute right heart failure
|
0.00%
0/30 • Each patient had adverse event data recorded through study completion and surgical follow-up, which was an average of one month.
Each patient was seen POD 1 or 2 by the regional service to assess for complications. Also, study team members reviewed each patient's hospital course until the time of discharge to assess for complications, and OnCore was used to enroll patients in the study, which flagged the study team if the patient was seen/admitted (if documented in EPIC) post-discharge for any potential complications that could be reviewed. Each patient had adverse event data recorded through study completion.
|
3.1%
1/32 • Number of events 1 • Each patient had adverse event data recorded through study completion and surgical follow-up, which was an average of one month.
Each patient was seen POD 1 or 2 by the regional service to assess for complications. Also, study team members reviewed each patient's hospital course until the time of discharge to assess for complications, and OnCore was used to enroll patients in the study, which flagged the study team if the patient was seen/admitted (if documented in EPIC) post-discharge for any potential complications that could be reviewed. Each patient had adverse event data recorded through study completion.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/30 • Each patient had adverse event data recorded through study completion and surgical follow-up, which was an average of one month.
Each patient was seen POD 1 or 2 by the regional service to assess for complications. Also, study team members reviewed each patient's hospital course until the time of discharge to assess for complications, and OnCore was used to enroll patients in the study, which flagged the study team if the patient was seen/admitted (if documented in EPIC) post-discharge for any potential complications that could be reviewed. Each patient had adverse event data recorded through study completion.
|
3.1%
1/32 • Number of events 32 • Each patient had adverse event data recorded through study completion and surgical follow-up, which was an average of one month.
Each patient was seen POD 1 or 2 by the regional service to assess for complications. Also, study team members reviewed each patient's hospital course until the time of discharge to assess for complications, and OnCore was used to enroll patients in the study, which flagged the study team if the patient was seen/admitted (if documented in EPIC) post-discharge for any potential complications that could be reviewed. Each patient had adverse event data recorded through study completion.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place