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Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

Primary Purpose

Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral Erector Spinae Plane Block (ESPB)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defect

Eligibility Criteria

0 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital Stanford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erector Spinae Plane Block

Arm Description

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.

Outcomes

Primary Outcome Measures

Median time to extubation in patients with ESPB
Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB
Determine average post-operative pain scores in patients with ESPB
Determine opioid consumption

Secondary Outcome Measures

Full Information

First Posted
July 26, 2018
Last Updated
September 25, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03611374
Brief Title
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
Official Title
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Erector Spinae Plane Block (ESPB)
Intervention Description
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 Outcome Measure Information:
Title
Median time to extubation in patients with ESPB
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Determine average post-operative pain scores in patients with ESPB
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Determine opioid consumption
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Caruso, MD, MEd
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

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