Regional Anesthesia for Cardiothoracic Enhanced Recovery

Study Overview
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Brief Summary
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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.

Official Title
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Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy

Conditions
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Opioid Use, Anesthesia, Local, Cardiac Disease, Pain, Acute

Intervention / Treatment
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* Procedure: Bilateral ESP catheter with lidocaine
* Procedure: Bilateral ESP catheter with saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral ESP catheter with Lidocaine<br>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<br>* 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).<br>|
| Placebo Comparator: Bilateral ESP catheter with saline<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | IV and PO opioid requirements converted to morphine equivalent | Duration of postoperative recovery (typically 1-2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium and agitation post-operatively | Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated. | Duration of ICU stay (typically 2-5 days) | 
| Determine post-operative pain scores | 11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain. | Duration of postoperative recovery (typically 1-2 weeks) | 
| Median time to extubation in patients with ESPB | duration in mechanical ventilation in hours | Duration of postoperative recovery (typically 1-2 weeks) | 
| Length of stay in hospital | number of post-operative days spent in hospital | Duration of postoperative recovery (typically 1-2 weeks) | 
| Length of stay in ICU | number of post-operative days spent in ICU | Duration of postoperative recovery (typically 1-2 weeks) | 
| 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. | post-operative day 3 | 
| 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. | First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure |