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Clinical Trials/NCT04770961
NCT04770961
Unknown
Not Applicable

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

University of California, San Francisco1 site in 1 country50 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
University of California, San Francisco
Enrollment
50
Locations
1
Primary Endpoint
Total opiate consumption
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
August 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total opiate consumption

Time Frame: 48 hours.

Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record.

Secondary Outcomes

  • Length of hospital stay(Within 30 days from end of operation.)
  • Pain score(48 hours)
  • Time to extubation.(Within 30 days from end of operation.)
  • Length of intensive care stay(Within 30 days from end of operation.)
  • Time to chest tube removal(Within 30 days from end of operation.)
  • Time to first oral intake(Within 30 days from end of operation.)
  • Time to ambulation(Within 30 days from end of operation.)
  • Patient self-reported experience with surgery and postoperative recovery(30 days after hospital discharge.)

Study Sites (1)

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