Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

Not Applicable

Completed

• Conditions: Congenital Heart Defect; Congenital Heart Disease; Opioid Use; Anesthesia, Local
• Interventions: Procedure: Bilateral Erector Spinae Plane Block (ESPB)

• Registration Number: NCT03611374
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Study Start: 2019-06-07
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	Bilateral Erector Spinae Plane Block (ESPB)	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.

Primary Outcome Measures

Name	Time	Method
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)
Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB	Duration of postoperative recovery (typically 1-2 weeks)
Median time to extubation in patients with ESPB	Duration of postoperative recovery (typically 1-2 weeks)

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States