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| Name | Class |
|---|---|
| The Society of Pediatric Anesthesia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional Anesthesia | Active Comparator | Ultrasound guided blocks |
|
| Wound Infiltration | Active Comparator | Surgeon-delivered wound infiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia | Procedure | Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Up to 12 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery |
| Total Amount of Opioid Medications Administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Einhorn, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41032451 | Derived | Einhorn LM, Kharasch ED, Lim J, Fuller M, Turi JL, Jooste EH, Andrew BY, Ames WA. Combined Pecto-intercostal Fascial Plane and Rectus Sheath Blocks Versus Local Infiltration for Pain Management Following Pediatric Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2026 Jun 1;142(6):1189-1197. doi: 10.1213/ANE.0000000000007754. Epub 2025 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed data collection for the primary and secondary outcomes (up to 48 hours after surgery) are reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Participants who completed the study | Posted | Mean | Standard Deviation | MME/kg | Up to 12 hours after surgery |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Einhorn, M.D. | Duke University Medical Center | (919) 668-4000 | lisa.einhorn@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2024 | Aug 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006345 | Heart Septal Defects, Ventricular |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
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| Wound infiltration | Procedure | Surgeon-delivered wound infiltration with Ropivacaine 0.2% |
|
| Ropivacaine 0.2% Injectable Solution | Drug | Ropivacaine 1.5 mL/kg will be used for both interventions |
|
Postoperative opioid medication expressed in morphine equivalents per kilogram |
| Up to 48 hours after surgery |
| 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. | 48 hours |
| Day of surgery cancellation |
|
| Reintubated on PCICU arrival |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Participants who completed the study | Posted | Mean | Standard Deviation | MME/kg | 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery |
|
|
|
|
| Secondary | Total Amount of Opioid Medications Administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Participants who completed the study | Posted | Mean | Standard Deviation | MME/kg | Up to 48 hours after surgery |
|
|
|
|
| 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. | Participants who completed the study | Posted | Mean | Standard Deviation | FLACC pain score (0-10)*hours | 48 hours |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
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| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 12-48 hours hours after surgery |
|
| 0.14 |
| Mean Difference (Final Values) |
| -0.16 |
| 2-Sided |
| 95 |
| -0.37 |
| 0.06 |
| Superiority |
| 12-48 hours hours after surgery | t-test, 2 sided | 0.16 | Mean Difference (Final Values) | -0.21 | 2-Sided | 95 | -0.52 | 0.09 | Superiority |