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Completed

NCT Number: NCT03611374

Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

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).

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Key information

Conditions

Congenital Heart Defect Anesthesia, Local Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Opioid Use

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral Erector Spinae Plane Block (ESPB)

Procedure

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.

Primary outcomes

  1. Median time to extubation in patients with ESPB

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

  2. Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

  3. Determine average post-operative pain scores in patients with ESPB

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

  4. Determine opioid consumption

    Time frame: Duration of postoperative recovery (typically 1-2 weeks)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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