Trial Outcomes & Findings for Regional Anesthesia Following Pediatric Cardiac Surgery (NCT NCT05688670)
NCT ID: NCT05688670
Last Updated: 2025-08-28
Results Overview
Postoperative opioid medication expressed in morphine equivalents per kilogram
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
Up to 12 hours after surgery
Results posted on
2025-08-28
Participant Flow
Participant milestones
| Measure |
Regional Anesthesia
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Regional Anesthesia
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Overall Study
Change in surgery plan
|
1
|
4
|
|
Overall Study
Inability to extubate
|
1
|
2
|
|
Overall Study
Day of surgery cancellation
|
0
|
1
|
|
Overall Study
Reintubated on PCICU arrival
|
0
|
1
|
Baseline Characteristics
Regional Anesthesia Following Pediatric Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Regional Anesthesia
n=24 Participants
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
n=18 Participants
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3 years
n=5 Participants
|
3 years
n=7 Participants
|
3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
18 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hours after surgeryPopulation: Participants who completed the study
Postoperative opioid medication expressed in morphine equivalents per kilogram
Outcome measures
| Measure |
Regional Anesthesia
n=24 Participants
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
n=18 Participants
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Total Amount of Opioid Medications Administered
|
0.44 MME/kg
Standard Deviation 0.19
|
0.83 MME/kg
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgeryPopulation: Participants who completed the study
Postoperative opioid medication expressed in morphine equivalents per kilogram
Outcome measures
| Measure |
Regional Anesthesia
n=24 Participants
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
n=18 Participants
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Total Amount of Opioid Medications Administered
12-24 hours after surgery
|
0.29 MME/kg
Standard Deviation 0.19
|
0.35 MME/kg
Standard Deviation 0.24
|
|
Total Amount of Opioid Medications Administered
24-48 hours after surgery
|
0.23 MME/kg
Standard Deviation 0.22
|
0.39 MME/kg
Standard Deviation 0.39
|
|
Total Amount of Opioid Medications Administered
12-48 hours hours after surgery
|
0.52 MME/kg
Standard Deviation 0.32
|
0.74 MME/kg
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Up to 48 hours after surgeryPopulation: Participants who completed the study
Postoperative opioid medication expressed in morphine equivalents per kilogram
Outcome measures
| Measure |
Regional Anesthesia
n=24 Participants
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
n=18 Participants
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Total Amount of Opioid Medications Administered
|
0.95 MME/kg
Standard Deviation 0.40
|
1.57 MME/kg
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Participants who completed the study
Cumulative burden of pain over time was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. Scores range from 0-10, with higher scores indicating greater pain.
Outcome measures
| Measure |
Regional Anesthesia
n=24 Participants
Ultrasound guided blocks Regional Anesthesia: Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
Wound Infiltration
n=18 Participants
Surgeon-delivered wound infiltration Wound infiltration: Surgeon-delivered wound infiltration with Ropivacaine 0.2% Ropivacaine 0.2% Injectable Solution: Ropivacaine 1.5 mL/kg will be used for both interventions
|
|---|---|---|
|
Postoperative Pain Intensity AUC
|
45.0 FLACC pain score (0-10)*hours
Standard Deviation 26.8
|
94.5 FLACC pain score (0-10)*hours
Standard Deviation 55.7
|
Adverse Events
Regional Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wound Infiltration
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place