Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER)

Stanford University

Status: Active, not recruiting

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

Treatments: Procedure: Bilateral ESP catheter with lidocaine; Procedure: Bilateral ESP catheter with saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03781440

47647

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Bilateral ESP catheter with Lidocaine

Experimental group

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).

Treatment:

Procedure: Bilateral ESP catheter with lidocaine

Bilateral ESP catheter with saline

Placebo Comparator group

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).

Treatment:

Procedure: Bilateral ESP catheter with saline