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Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Primary Purpose

Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Erector spinae plane catheter with 0.5% Ropivacaine

Erector spinae plane catheter with saline

About this trial

This is an interventional treatment trial for Mitral Regurgitation focused on measuring mitral valve replacement, mitral valve repair, mitral valve surgery, erector spinae plane, minimally invasive surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Cryoablation

ESP + Cryoablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Time to first oral intake

Length from ICU arrival to the time of first oral intake (hours). Extracted from electronic medical record.

Time to ambulation

Length from ICU arrival to the time of first ambulation (hours). Extracted from electronic medical record.

Time to chest tube removal

Length from ICU arrival to the time of last chest tube removal (hours). Extracted from electronic medical record.

Length of intensive care stay

Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record.

Length of hospital stay

Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.

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.

Full Information

NCT ID

NCT04770961

First Posted

February 22, 2021

Last Updated

March 1, 2021

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT04770961

Brief Title

Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

Official Title

Erector Spinae Plane Block for Minimally Invasive Mitral Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse

Keywords

mitral valve replacement, mitral valve repair, mitral valve surgery, erector spinae plane, minimally invasive surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cryoablation

Arm Type

Sham Comparator

Arm Description

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

Arm Title

ESP + Cryoablation

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane catheter with 0.5% Ropivacaine

Intervention Description

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

Intervention Name(s)

Erector spinae plane catheter with saline

Other Intervention Name(s)

Sham

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total opiate consumption

Description

Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record.

Time Frame

48 hours.

Secondary Outcome Measure Information:

Title

Pain score

Description

Time Frame

48 hours

Title

Time to extubation.

Description

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 Frame