Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

University of California San Francisco (UCSF)

Status: Unknown

Conditions: Mitral Valve Insufficiency; Mitral Regurgitation; Mitral Valve Prolapse

Treatments: Procedure: Erector spinae plane catheter with 0.5% Ropivacaine; Procedure: Erector spinae plane catheter with saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04770961

19-29298

Details and patient eligibility

About

The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).

Full description

This is a double blinded randomized controlled trial comparing a control group receiving cryoablation and sham block with an intervention group receiving cryoablation and ESP catheter. The primary outcome is total oral morphine equivalent (OME) consumption within the first 48 hours of recovery including intra-operative usage. Secondary outcomes to be evaluated would include pain scores, functional milestones like time to extubation, time to first PO intake, time to ambulation, time to chest tube removal, length of ICU and total hospital stay, complications, and patient satisfaction.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective mitral valve repair or replacement
• Planned minimally invasive approach

Exclusion criteria

• Non-English speaking
• Emergency surgery
• Planned or unplanned sternotomy
• Previous history of sternotomy and cardiac surgery
• Allergy to ropivacaine
• Patients taking more than 60 OMEs per day
• Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Cryoablation

Sham Comparator group

Description:

1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.

Treatment:

Procedure: Erector spinae plane catheter with saline

ESP + Cryoablation

Experimental group

Description:

2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.

Treatment:

Procedure: Erector spinae plane catheter with 0.5% Ropivacaine