Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Not Applicable

• Conditions: Mitral Regurgitation; Mitral Valve Insufficiency; Mitral Valve Prolapse
• Interventions: Procedure: Erector spinae plane catheter with saline; Procedure: Erector spinae plane catheter with 0.5% Ropivacaine

• Registration Number: NCT04770961
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03
• Study Start: 2021-04-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Erector spinae plane catheter with saline	1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.
ESP + Cryoablation	Erector spinae plane catheter with 0.5% Ropivacaine	2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.

Primary Outcome Measures

Name	Time	Method
Total opiate consumption	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 Outcome Measures

Name	Time	Method
Length of hospital stay	Within 30 days from end of operation.	Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.
Pain score	48 hours	Pain Scores will be measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain, assessed by nursing staff, and extracted from electronic medical record.
Time to extubation.	Within 30 days from end of operation.	Length from ICU arrival to endotracheal extubation (minutes). If extubated in the operating room, the time will be 0 minute. Extracted from electronic medical record.
Length of intensive care stay	Within 30 days from end of operation.	Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record.
Time to chest tube removal	Within 30 days from end of operation.	Length from ICU arrival to the time of last chest tube removal (hours). Extracted from electronic medical record.
Time to first oral intake	Within 30 days from end of operation.	Length from ICU arrival to the time of first oral intake (hours). Extracted from electronic medical record.
Time to ambulation	Within 30 days from end of operation.	Length from ICU arrival to the time of first ambulation (hours). Extracted from electronic medical record.
Patient self-reported experience with surgery and postoperative recovery	30 days after hospital discharge.	Based on questionnaires regarding the patient's experience with the efficacy of pain control and the satisfaction with postoperative recovery with scores from 1 (not satisfied at all) to 5 (very satisfied) conducted over telephone or video conferencing.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States