Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

March 1, 2021 updated by: University of California, San Francisco

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opiate consumption
Time Frame: 48 hours.
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
Time Frame: 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.
48 hours
Time to extubation.
Time Frame: 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.
Within 30 days from end of operation.
Time to first oral intake
Time Frame: Within 30 days from end of operation.
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
Time Frame: Within 30 days from end of operation.
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
Time Frame: 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.
Within 30 days from end of operation.
Length of intensive care stay
Time Frame: Within 30 days from end of operation.
Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record.
Within 30 days from end of operation.
Length of hospital stay
Time Frame: Within 30 days from end of operation.
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
Time Frame: 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.
30 days after hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Wilson Cui, MD, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-29298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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