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Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER)

Primary Purpose

Opioid Use, Anesthesia, Local, Cardiac Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral ESP catheter with lidocaine
Bilateral ESP catheter with saline
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Give consent to participate in study
  • planned sternotomy
  • specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
  • Primary or first redo sternotomy

Exclusion Criteria:

  • Participants who cannot give consent
  • Patients who are clinically unstable or require urgent/emergent intervention
  • more than1 prior sternotomy
  • planned aortic arch procedures
  • preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)
  • Severe ventricular dysfunction (left or right ventricle)
  • Symptomatic heart failure (systolic or diastolic)

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bilateral ESP catheter with Lidocaine

Bilateral ESP catheter with saline

Arm Description

All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).

All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).

Outcomes

Primary Outcome Measures

Opioid Consumption
IV and PO opioid requirements converted to morphine equivalent

Secondary Outcome Measures

Delirium and agitation post-operatively
Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated.
Determine post-operative pain scores
11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain.
Median time to extubation in patients with ESPB
duration in mechanical ventilation in hours
Length of stay in hospital
number of post-operative days spent in hospital
Length of stay in ICU
number of post-operative days spent in ICU
Quality of recovery at 72 hours
Survey based (Quality of Recover 15) patient reported outcomes. There are 15 questions based on a scale of 0-10 per questions, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150.
Inflammatory biomarker analysis
Pro and anti-inflammatory biomarker panel at 4 time points perioperatively. We will be analyzing IL10 concentrations as an anti-inflammatory biomarker and IL6 and TN alpha as pro-inflammatory biomarkers in either a ELISA assay or Luminex.

Full Information

First Posted
December 18, 2018
Last Updated
September 20, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03781440
Brief Title
Regional Anesthesia for Cardiothoracic Enhanced Recovery
Acronym
RACER
Official Title
Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

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 (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Anesthesia, Local, Cardiac Disease, Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral ESP catheter with Lidocaine
Arm Type
Experimental
Arm Description
All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Arm Title
Bilateral ESP catheter with saline
Arm Type
Placebo Comparator
Arm Description
All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Intervention Type
Procedure
Intervention Name(s)
Bilateral ESP catheter with lidocaine
Intervention Description
All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Intervention Type
Procedure
Intervention Name(s)
Bilateral ESP catheter with saline
Intervention Description
All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
IV and PO opioid requirements converted to morphine equivalent
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Secondary Outcome Measure Information:
Title
Delirium and agitation post-operatively
Description
Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated.
Time Frame
Duration of ICU stay (typically 2-5 days)
Title
Determine post-operative pain scores
Description
11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain.
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Median time to extubation in patients with ESPB
Description
duration in mechanical ventilation in hours
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Length of stay in hospital
Description
number of post-operative days spent in hospital
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Length of stay in ICU
Description
number of post-operative days spent in ICU
Time Frame
Duration of postoperative recovery (typically 1-2 weeks)
Title
Quality of recovery at 72 hours
Description
Survey based (Quality of Recover 15) patient reported outcomes. There are 15 questions based on a scale of 0-10 per questions, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150.
Time Frame
post-operative day 3
Title
Inflammatory biomarker analysis
Description
Pro and anti-inflammatory biomarker panel at 4 time points perioperatively. We will be analyzing IL10 concentrations as an anti-inflammatory biomarker and IL6 and TN alpha as pro-inflammatory biomarkers in either a ELISA assay or Luminex.
Time Frame
First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Give consent to participate in study planned sternotomy specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these Primary or first redo sternotomy Exclusion Criteria: Participants who cannot give consent Patients who are clinically unstable or require urgent/emergent intervention more than1 prior sternotomy planned aortic arch procedures preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy) Severe ventricular dysfunction (left or right ventricle) Symptomatic heart failure (systolic or diastolic)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Brodt, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ban Tsui, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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14622770
Citation
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Regional Anesthesia for Cardiothoracic Enhanced Recovery

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