Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedMarch 3, 2021
March 1, 2021
1.2 years
February 22, 2021
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Pain score
48 hours
Time to extubation.
Within 30 days from end of operation.
Time to first oral intake
Within 30 days from end of operation.
Time to ambulation
Within 30 days from end of operation.
Time to chest tube removal
Within 30 days from end of operation.
- +3 more secondary outcomes
Study Arms (2)
Cryoablation
SHAM COMPARATOR1\. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.
ESP + Cryoablation
EXPERIMENTAL2\. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Elective mitral valve repair or replacement
- Planned minimally invasive approach
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson Cui, MD, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
April 1, 2021
Primary Completion
June 30, 2022
Study Completion
August 30, 2022
Last Updated
March 3, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share