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Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER)

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ClinicalTrials.gov Identifier: NCT03781440
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

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.

Condition or disease Intervention/treatment Phase
Opioid Use Anesthesia, Local Cardiac Disease Pain, Acute Procedure: Bilateral ESP catheter with lidocaine Procedure: Bilateral ESP catheter with saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bilateral ESP catheter with Lidocaine
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).
Procedure: Bilateral ESP catheter with lidocaine
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).

Placebo Comparator: Bilateral ESP catheter with saline
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).
Procedure: Bilateral ESP catheter with saline
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 Measures :
  1. Median time to extubation in patients with ESPB [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
    duration in mechanical ventilation in hours

  2. Length of stay in ICU [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks ]
    number of days spent in ICU

  3. Opioid Consumption [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
    IV and PO opioid requirements converted to morphine equivalent

  4. Determine average post-operative pain scores in patients with ESPB [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
    NRS scale of 0-10



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Known heart failure (systolic or diastolic)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781440


Contacts
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Contact: Jessica Brodt, MD 350-331-1075 jbrodt@stanford.edu
Contact: Swaraoop Mistry, MS 4084993037 smistry3@stanford.edu

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Archana Verma         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Ban Tsui, MD Stanford University

Publications:

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Responsible Party: Chi-Ho Ban Tsui, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03781440     History of Changes
Other Study ID Numbers: 47647
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Heart Diseases
Acute Pain
Cardiovascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action