Trial Outcomes & Findings for Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery (NCT NCT02512861)
NCT ID: NCT02512861
Last Updated: 2018-08-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
Day of Surgery and Postoperative Day 1
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
Bupivacaine
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
49
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Bupivacaine
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
7
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1 years
n=5 Participants
|
0.8 years
n=7 Participants
|
0.84 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bi-racial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
40 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Comorbidities
Respiratory
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Gastrointestinal
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Comorbidities
Genetic
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Comorbidities
Neurodevelopmental/Developmental Delay
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
None
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Comorbidities
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery and Postoperative Day 1Outcome measures
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Total Fentanyl/Equivalent Day 0-1
|
23.6 mcg/kg/day
Interval 10.7 to 34.3
|
22.4 mcg/kg/day
Interval 13.3 to 32.6
|
PRIMARY outcome
Timeframe: Day of Surgery and Postoperative Day 1Outcome measures
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1
|
15.7 mcg/kg/day
Interval 8.5 to 22.1
|
14.6 mcg/kg/day
Interval 10.6 to 21.7
|
SECONDARY outcome
Timeframe: 5 days post cardiac surgeryOutcome measures
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Postoperative Length of Intubation
|
5.9 hours
Interval 3.7 to 19.5
|
6.4 hours
Interval 3.3 to 22.1
|
SECONDARY outcome
Timeframe: 12 hours post-surgeryOutcome measures
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Postoperative Cortisol Levels
|
25.4 microgram/deciliter
Interval 15.5 to 44.8
|
27.7 microgram/deciliter
Interval 14.9 to 59.4
|
SECONDARY outcome
Timeframe: Day of SurgeryFace, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).
Outcome measures
| Measure |
Bupivacaine
n=24 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=28 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale
|
0 score on a scale
Interval 0.0 to 2.88
|
0 score on a scale
Interval 0.0 to 1.15
|
SECONDARY outcome
Timeframe: Day of SurgeryState Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).
Outcome measures
| Measure |
Bupivacaine
n=24 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=28 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Postoperative Pain Scores-State Behavioral Scale (SBS)
|
-0.25 score on a scale
Interval -1.0 to 1.0
|
-0.25 score on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: 36 hours post-surgeryOutcome measures
| Measure |
Bupivacaine
n=38 Participants
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 Participants
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Postoperative Cortisol Levels
|
9.4 microgram/deciliter
Interval 5.1 to 17.3
|
9.1 microgram/deciliter
Interval 3.6 to 20.7
|
Adverse Events
Bupivacaine
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine
n=38 participants at risk
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
Bupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs
|
Placebo
n=40 participants at risk
Normal Saline
Placebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shallow Breathing/Increased Work of Breathing
|
0.00%
0/38 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
|
Blood and lymphatic system disorders
Significant blood/chest tube losses requiring transfusion or fluid resuscitation
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax or Pleural effusion
|
0.00%
0/38 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory syncytial virus leading to pneumonia
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
0.00%
0/40 • Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
|
Other adverse events
Adverse event data not reported
Additional Information
Mark Lo Galbo, MPH, CCRP
Children's Hospitals and Clinics of Minnesota
Phone: (612)-813-7828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place