An interventional study of Erector spinae plane catheter with 0.5% Ropivacaine and Erector spinae plane catheter with saline in Mitral Regurgitation, Mitral Valve Insufficiency and Mitral Valve Prolapse, sponsored by University of California, San Francisco. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 50 is below the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion.
Procedure: Erector spinae plane catheter with saline
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.
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.
Also known as: Sham
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.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco