MedPath

Regional Anesthesia for Cardiothoracic Enhanced Recovery

Not Applicable
Active, not recruiting
Conditions
Opioid Use
Anesthesia, Local
Cardiac Disease
Pain, Acute
Interventions
Procedure: Bilateral ESP catheter with lidocaine
Procedure: Bilateral ESP catheter with saline
Registration Number
NCT03781440
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
60
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bilateral ESP catheter with LidocaineBilateral ESP catheter with lidocaineAll 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).
Bilateral ESP catheter with salineBilateral ESP catheter with salineAll 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
NameTimeMethod
Opioid ConsumptionDuration of postoperative recovery (typically 1-2 weeks)

IV and PO opioid requirements converted to morphine equivalent

Secondary Outcome Measures
NameTimeMethod
Length of stay in ICUDuration of postoperative recovery (typically 1-2 weeks)

number of post-operative days spent in ICU

Inflammatory biomarker analysisFirst panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure

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.

Delirium and agitation post-operativelyDuration of ICU stay (typically 2-5 days)

Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated.

Quality of recovery at 72 hourspost-operative day 3

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.

Determine post-operative pain scoresDuration of postoperative recovery (typically 1-2 weeks)

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 ESPBDuration of postoperative recovery (typically 1-2 weeks)

duration in mechanical ventilation in hours

Length of stay in hospitalDuration of postoperative recovery (typically 1-2 weeks)

number of post-operative days spent in hospital

Trial Locations

Locations (1)

Stanford University

🇺🇸

Stanford, California, United States

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