Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04770961

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Mitral Valve Insufficiency Mitral Valve Prolapse	Procedure: Erector spinae plane catheter with 0.5% Ropivacaine Procedure: Erector spinae plane catheter with saline	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Cryoablation 1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.	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. Other Names: Sham
Experimental: ESP + Cryoablation 2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.	Procedure: 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.

Arm

Intervention/Treatment

Sham Comparator: Cryoablation

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

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.

Other Names:

Sham

Experimental: ESP + Cryoablation

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.
Length of hospital stay [Within 30 days from end of operation.]
Length from ICU arrival to hospital discharge (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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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