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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Sham Comparator | 1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion. |
|
| ESP + Cryoablation | Experimental | 2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane catheter with 0.5% Ropivacaine | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to extubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wilson Cui, MD, PhD | Contact | 415-476-6783 | Wilson.Cui@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wilson Cui, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016127 | Heart Valve Prolapse |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Erector spinae plane catheter with saline | Procedure | 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. |
|
|
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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Length of hospital stay | Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record. | 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. | 30 days after hospital discharge. |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |