Trial Outcomes & Findings for Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients (NCT NCT05676814)
NCT ID: NCT05676814
Last Updated: 2024-06-11
Results Overview
Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
0 to 6 hours after block placement
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Pecto-intercostal Fascial Block (PIFB)
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Baseline characteristics by cohort
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=16 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=15 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 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
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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 (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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 6 hours after block placementBased on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
|
6.39 scores on a scale*hour
Standard Deviation 3.23
|
4.22 scores on a scale*hour
Standard Deviation 3.76
|
PRIMARY outcome
Timeframe: 12 hours after block placementBased on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
|
3.28 scores on a scale*hour
Standard Deviation 2.03
|
4.06 scores on a scale*hour
Standard Deviation 3.65
|
PRIMARY outcome
Timeframe: 18 hours after block placementBased on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
|
4.00 scores on a scale*hour
Standard Deviation 2.09
|
5.12 scores on a scale*hour
Standard Deviation 3.23
|
PRIMARY outcome
Timeframe: 24 hours after block placementBased on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
|
3.18 scores on a scale*hour
Standard Deviation 2.19
|
4.71 scores on a scale*hour
Standard Deviation 3.06
|
PRIMARY outcome
Timeframe: 36 hours after block placementPopulation: data wasn't collected
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 hours after block placementPain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
|
5.25 units on a scale
Standard Deviation 3.22
|
3.43 units on a scale
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: 6, 12, 18, 24 hours after block placementPain scores range from 0 to 10 with higher scores denoting more pain.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
6 hour
|
5.25 units on a scale
Standard Deviation 3.22
|
3.43 units on a scale
Standard Deviation 4.24
|
|
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
12 hour
|
2.67 units on a scale
Standard Deviation 2.02
|
3.14 units on a scale
Standard Deviation 3.18
|
|
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
18 hour
|
2.45 units on a scale
Standard Deviation 2.42
|
3.5 units on a scale
Standard Deviation 3.25
|
|
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
24 hour
|
3.09 units on a scale
Standard Deviation 2.26
|
3.5 units on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: 36 hours after block placementPopulation: data wasn't collected
Average Cumulative Opioid Consumption in milligrams
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 hours after block placementPopulation: data not collected
Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 hours after block placementAverage Time to Extubation - measured in minutes
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Average Time to Extubation
|
276.815 Minutes
Standard Deviation 78.609
|
232.020 Minutes
Standard Deviation 68.689
|
SECONDARY outcome
Timeframe: Up to 52 hours after block placementDuration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Duration of Intensive Care Unit (ICU) Admission
|
50.620 Hours
Standard Deviation 32.302
|
51.541 Hours
Standard Deviation 59.249
|
SECONDARY outcome
Timeframe: 6, 12, 18, 24 hours after block placementAn incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Incentive Spirometry Volumes
18 hours
|
878.79 Milliliters
Standard Deviation 336.08
|
1440.63 Milliliters
Standard Deviation 794.07
|
|
Incentive Spirometry Volumes
24 hours
|
1093.94 Milliliters
Standard Deviation 337.25
|
1275 Milliliters
Standard Deviation 498.65
|
|
Incentive Spirometry Volumes
Baseline
|
2750 Milliliters
Standard Deviation 823.43
|
3427.08 Milliliters
Standard Deviation 743.27
|
|
Incentive Spirometry Volumes
6 hours
|
525 Milliliters
Standard Deviation 338.56
|
1333.33 Milliliters
Standard Deviation 857.97
|
|
Incentive Spirometry Volumes
12 hours
|
968.06 Milliliters
Standard Deviation 287.14
|
1519.44 Milliliters
Standard Deviation 716.12
|
SECONDARY outcome
Timeframe: Up to 36 hours after block placementPopulation: data wasn't collected
Average number of incidences of Nausea
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 hours after block placementPopulation: data wasn't collected
Average number of Vomiting incidences
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 hours after block placementPopulation: data wasn't collected
Average number of Delirium incidences
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 hours after block placementPatient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
Outcome measures
| Measure |
Pecto-intercostal Fascial Block (PIFB)
n=12 Participants
Subjects in this arm receive standard of care PIFB after surgery
Pecto-intercostal Fascial Block (PIFB): PIFB done with bupivacaine and epinephrine
|
PIFB With Adjuvants
n=8 Participants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
PIFB with adjuvants: PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
|---|---|---|
|
Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen
|
7.92 units on a scale
Standard Deviation 1.98
|
8.88 units on a scale
Standard Deviation .99
|
Adverse Events
Pecto-intercostal Fascial Block (PIFB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PIFB With Adjuvants
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
Scott Coleman, DO
Wake Forest University Health Sciences
Phone: 336-716-2712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place