Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

September 25, 2023 updated by: Thomas Caruso, Stanford University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block
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)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Thomas Caruso, MD, MEd, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2019

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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