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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: 48 hours.
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 frame: 48 hours
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 frame: Within 30 days from end of operation.
Time to first oral intake
Length from ICU arrival to the time of first oral intake (hours). Extracted from electronic medical record.
Time frame: Within 30 days from end of operation.
Time to ambulation
Length from ICU arrival to the time of first ambulation (hours). Extracted from electronic medical record.
Time frame: Within 30 days from end of operation.
Time to chest tube removal
Length from ICU arrival to the time of last chest tube removal (hours). Extracted from electronic medical record.
Time frame: Within 30 days from end of operation.
Length of intensive care stay
Length from ICU arrival to ICU discharge (hours). Extracted from electronic medical record.
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Time frame: Within 30 days from end of operation.
Length of hospital stay
Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.
Time frame: Within 30 days from end of operation.
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.
Time frame: 30 days after hospital discharge.