Regional Anesthesia Following Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study

Conditions
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Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural

Intervention / Treatment
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* Procedure: Regional Anesthesia
* Procedure: Wound infiltration
* Drug: Ropivacaine 0.2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children less than 18 years old Presenting for primary atrial septal defect or ventricular septal defect repair Informed consent / assent provided Exclusion Criteria: Patients on opioid therapy at the time of surgery History of sternotomy Planned postoperative intubation Current diagnosis of a chronic pain syndrome.

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regional Anesthesia<br>Ultrasound guided blocks | Procedure: Regional Anesthesia<br>* Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%<br>Drug: Ropivacaine 0.2% Injectable Solution<br>* Ropivacaine 1.5 mL/kg will be used for both interventions<br>|
| Active Comparator: Wound Infiltration<br>Surgeon-delivered wound infiltration | Procedure: Wound infiltration<br>* Surgeon-delivered wound infiltration with Ropivacaine 0.2%<br>Drug: Ropivacaine 0.2% Injectable Solution<br>* Ropivacaine 1.5 mL/kg will be used for both interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of opioid medications administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | 12 to 24 hours after surgery | 
| Total amount of opioid medications administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | 24 to 48 hours after surgery | 
| Total amount of opioid medications administered | Postoperative opioid medication expressed in morphine equivalents per kilogram | Up to 48 hours after surgery | 
| Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale | Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain | within the first 12 hours after surgery | 
| Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale | Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain | 12 to 24 hours after surgery | 
| Pain Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale | Face, Legs, Activity, Cry, Consolability (FLACC) Scale, 0-10. 0 no pain, 10 worst possible pain | 24 to 48 hours after surgery | 
| Pain Intensity as measured by Numeric Rating Scale | Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain | within the first 12 hours after surgery | 
| Pain Intensity as measured by Numeric Rating Scale | Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain | 12 to 24 hours after surgery | 
| Pain Intensity as measured by Numeric Rating Scale | Visual Analog Scale and Numeric Rating Scale, 0-10. 0 no pain, 10 worst possible pain | 24 to 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia