Mitral Regurgitation Clinical Trial
Official title:
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. |
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