NCT04770961

Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Prolapse

Interventions

Type	Name	Description
PROCEDURE	Erector spinae plane catheter with 0.5% Ropivacaine	Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of 0.5% Ropivacaine is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of 0.2% Ropivacaine will be delivered via the ESP catheter.
PROCEDURE	Erector spinae plane catheter with saline	Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of saline is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of saline will be delivered via the ESP catheter.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-06-30
• Completion: 2022-08-30
• First posted: 2021-02-25
• Last updated: 2021-03-03

Locations

1 site across 1 country: United States