Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

Conditions
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Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse

Intervention / Treatment
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* Procedure: Erector spinae plane catheter with 0.5% Ropivacaine
* Procedure: Erector spinae plane catheter with saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Cryoablation<br>1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion. | Procedure: Erector spinae plane catheter with saline<br>* 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.<br>* Other names: Sham;|
| Experimental: ESP + Cryoablation<br>2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion. | Procedure: Erector spinae plane catheter with 0.5% Ropivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opiate consumption | Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record. | 48 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | 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. | 48 hours | 
| Time to extubation. | 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. | Within 30 days from end of operation. | 
| Time to first oral intake | Length from ICU arrival to the time of first oral intake (hours). Extracted from electronic medical record. | Within 30 days from end of operation. | 
| Time to ambulation | Length from ICU arrival to the time of first ambulation (hours). Extracted from electronic medical record. | Within 30 days from end of operation. | 
| Time to chest tube removal | Length from ICU arrival to the time of last chest tube removal (hours). Extracted from electronic medical record. | Within 30 days from end of operation. | 
| Length of intensive care stay | Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record. | Within 30 days from end of operation. | 
| Length of hospital stay | Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record. | Within 30 days from end of operation. | 
| Patient self-reported experience with surgery and postoperative recovery | 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. | 30 days after hospital discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve replacement, mitral valve repair, mitral valve surgery, erector spinae plane, minimally invasive surgery