Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-08-30

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).

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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.

Conditions

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Mitral Regurgitation Mitral Valve Insufficiency Mitral Valve Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Cryoablation

1\. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.

Group Type SHAM_COMPARATOR

Erector spinae plane catheter with saline

Intervention Type PROCEDURE

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.

ESP + Cryoablation

2\. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.

Group Type EXPERIMENTAL

Erector spinae plane catheter with 0.5% Ropivacaine

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Sham

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No