Regional Anesthesia for Cardiothoracic Enhanced Recovery

Stanford University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Opioid Use Anesthesia, Local Cardiac Disease Pain, Acute

Interventions

Bilateral ESP catheter with lidocainePROCEDURE

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).

Bilateral ESP catheter with salinePROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Opioid Consumption

IV and PO opioid requirements converted to morphine equivalent

Time frame: Duration of postoperative recovery (typically 1-2 weeks)

Secondary Outcomes

Delirium and agitation post-operatively

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)

Determine post-operative pain scores

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)

Median time to extubation in patients with ESPB

duration in mechanical ventilation in hours

Time frame: Duration of postoperative recovery (typically 1-2 weeks)

Length of stay in hospital

number of post-operative days spent in hospital

Time frame: Duration of postoperative recovery (typically 1-2 weeks)

Length of stay in ICU

number of post-operative days spent in ICU

Time frame: 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.

Time frame: post-operative day 3

Data from ClinicalTrials.gov

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