Atrial Septal Defect, Pain, Procedural, Ventricular Septal Defect
Conditions
Keywords
Regional anesthesia
Brief summary
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
Detailed description
This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.
Interventions
PROCEDURERegional Anesthesia
Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
PROCEDUREWound infiltration
Surgeon-delivered wound infiltration with Ropivacaine 0.2%
DRUGRopivacaine 0.2% Injectable Solution
Ropivacaine 1.5 mL/kg will be used for both interventions
Sponsors
The Society of Pediatric Anesthesia
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children less than 18 years old 2. Presenting for primary atrial septal defect or ventricular septal defect repair 3. Informed consent / assent provided
Exclusion criteria
1. Patients on opioid therapy at the time of surgery 2. History of sternotomy 3. Planned postoperative intubation 4. Current diagnosis of a chronic pain syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Opioid Medications Administered | Up to 12 hours after surgery | Postoperative opioid medication expressed in morphine equivalents per kilogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Opioid Medications Administered | 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery | Postoperative opioid medication expressed in morphine equivalents per kilogram |
| Postoperative Pain Intensity AUC | 48 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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 | 18 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change in surgery plan | 1 | 4 |
| Overall Study | Day of surgery cancellation | 0 | 1 |
| Overall Study | Inability to extubate | 1 | 2 |
| Overall Study | Reintubated on PCICU arrival | 0 | 1 |
Baseline characteristics
| Characteristic | Regional Anesthesia | Total | Wound Infiltration |
|---|---|---|---|
| Age, Continuous | 3 years | 3 years | 3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 34 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 29 Participants | 11 Participants |
| Region of Enrollment United States | 24 participants | 42 participants | 18 participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time frame: Up to 12 hours after surgery
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Total Amount of Opioid Medications Administered | 0.44 MME/kg | Standard Deviation 0.19 |
| Wound Infiltration | Total Amount of Opioid Medications Administered | 0.83 MME/kg | Standard Deviation 0.39 |
p-value: 0.00195% CI: [-0.59, -0.18]t-test, 2 sided
Secondary
Postoperative Pain Intensity AUC
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.
Time frame: 48 hours
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Postoperative Pain Intensity AUC | 45.0 FLACC pain score (0-10)*hours | Standard Deviation 26.8 |
| Wound Infiltration | Postoperative Pain Intensity AUC | 94.5 FLACC pain score (0-10)*hours | Standard Deviation 55.7 |
p-value: 0.00295% CI: [-78.9, -20.1]t-test, 2 sided
Secondary
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time frame: 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regional Anesthesia | Total Amount of Opioid Medications Administered | 12-24 hours after surgery | 0.29 MME/kg | Standard Deviation 0.19 |
| Regional Anesthesia | Total Amount of Opioid Medications Administered | 24-48 hours after surgery | 0.23 MME/kg | Standard Deviation 0.22 |
| Regional Anesthesia | Total Amount of Opioid Medications Administered | 12-48 hours hours after surgery | 0.52 MME/kg | Standard Deviation 0.32 |
| Wound Infiltration | Total Amount of Opioid Medications Administered | 12-24 hours after surgery | 0.35 MME/kg | Standard Deviation 0.24 |
| Wound Infiltration | Total Amount of Opioid Medications Administered | 24-48 hours after surgery | 0.39 MME/kg | Standard Deviation 0.39 |
| Wound Infiltration | Total Amount of Opioid Medications Administered | 12-48 hours hours after surgery | 0.74 MME/kg | Standard Deviation 0.56 |
Comparison: 12-24 hour postoperative opioid usep-value: 0.4195% CI: [-0.2, 0.08]t-test, 2 sided
Comparison: 24-48 hour postoperative opioid usep-value: 0.1495% CI: [-0.37, 0.06]t-test, 2 sided
Comparison: 12-48 hours hours after surgeryp-value: 0.1695% CI: [-0.52, 0.09]t-test, 2 sided
Secondary
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time frame: Up to 48 hours after surgery
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Total Amount of Opioid Medications Administered | 0.95 MME/kg | Standard Deviation 0.4 |
| Wound Infiltration | Total Amount of Opioid Medications Administered | 1.57 MME/kg | Standard Deviation 0.75 |
p-value: 0.00495% CI: [-1.02, -0.22]t-test, 2 sided