Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

Study Overview
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Brief Summary
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The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).

Official Title
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Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair

Conditions
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Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local, Opioid Use

Intervention / Treatment
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* Procedure: Bilateral Erector Spinae Plane Block (ESPB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries Exclusion Criteria: i) Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector Spinae Plane Block<br>All participants will get the Erector Spinae Plane block (ESPB) as a prospective cohort study. After anesthesia induction all enrolled patients will have bilateral ESPB catheters placed at the T7 spine level prior to surgery. The surgery is a sternotomy for congenital heart repair in high risk children and adults. | Procedure: Bilateral Erector Spinae Plane Block (ESPB)<br>* Bilateral ESPBs will be placed after anesthesia induction in eligible and consented patients who are undergoing a sternotomy for congenital heart repair. Patients will receive a local anesthetic agent through each catheter prior to surgery start. If possible, levels of the local anesthetic will be measured during the case. After surgery, patients will be admitted to the CVICU and extubation will be managed by the CVICU team. The ESPB group will have an automatic, alternating side boluses of the local anesthetic started through their nerve block catheters. Levels of the local anesthetic will be measured at intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to extubation in patients with ESPB |  | Duration of postoperative recovery (typically 1-2 weeks) | 
| Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB |  | Duration of postoperative recovery (typically 1-2 weeks) | 
| Determine average post-operative pain scores in patients with ESPB |  | Duration of postoperative recovery (typically 1-2 weeks) | 
| Determine opioid consumption |  | Duration of postoperative recovery (typically 1-2 weeks) |