Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Mitral Regurgitation Clinical Trial

Official title:

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04770961
• Other study ID #: 19-29298
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2021
• Source: University of California, San Francisco
• Contact: Wilson Cui, MD, PhD
• Phone: 415-476-6783
• Email: Wilson.Cui[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Length of hospital stay	Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.	Within 30 days from end of operation.
Secondary	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.