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Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

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ClinicalTrials.gov Identifier: NCT04770961
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770961


Contacts
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Contact: Wilson Cui, MD, PhD 415-476-6783 Wilson.Cui@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Wilson Cui, MD, PhD    415-476-6783    wilson.cui@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Wilson Cui, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04770961    
Other Study ID Numbers: 19-29298
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
mitral valve replacement
mitral valve repair
mitral valve surgery
erector spinae plane
minimally invasive surgery
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Prolapse
Prolapse
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents