Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Wilson Cui

Description

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).

Official Title

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

Details

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.

Keywords

Mitral Regurgitation Mitral Valve Insufficiency Mitral Valve Prolapse mitral valve replacement mitral valve repair mitral valve surgery erector spinae plane minimally invasive surgery Prolapse Ropivacaine Erector spinae plane catheter with 0.5% Ropivacaine Erector spinae plane catheter with saline Cryoablation ESP + Cryoablation

Eligibility

You can join if…

Open to people ages 18-75

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

You CAN'T join if...

  • 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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04770961
Study Type
Interventional
Last Updated