Mitral RegurgitationNCT04770961
Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery
A study testing Erector spinae plane catheter with 0.5% Ropivacaine and Erector spinae plane catheter with saline in people with Mitral Regurgitation and Mitral Valve Insufficiency, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Insufficiency, Mitral Valve Prolapse
- What is being tested?
- Erector spinae plane catheter with 0.5% Ropivacaine and Erector spinae plane catheter with saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective mitral valve repair or replacement
- Planned minimally invasive approach
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Wilson Cui, MD, PhD, 415-476-6783, wilson.cui@ucsf.edu
About this study
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).
Read the detailed description
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.
- Being tested
- Erector spinae plane catheter with 0.5% Ropivacaine, Erector spinae plane catheter with saline
- Keywords
- mitral valve replacement, mitral valve repair, mitral valve surgery, erector spinae plane, minimally invasive surgery
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane catheter with 0.5% RopivacaineProcedure or surgery
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.
Erector spinae plane catheter with salineProcedure or surgery
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Sham comparator | 1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion. Receives: Procedure: Erector spinae plane catheter with saline |
| ESP + Cryoablation | Experimental | 2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion. Receives: Procedure: Erector spinae plane catheter with 0.5% Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days from end of operation.
Length of hospital stay
Length from ICU arrival to hospital discharge (Hours). Extracted from electronic medical record.
Measured: 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.
Measured: 30 days after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson Cui, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770961
- Sponsor's protocol ID
- 19-29298
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Minimally Invasive Mitral Surgery
- ClinicalTrials.gov ID
- NCT04770961
- Acronym / sponsor ID
- 19-29298
- Keywords
- mitral valve replacement, mitral valve repair, mitral valve surgery, erector spinae plane, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Sham comparator | Procedure: Erector spinae plane catheter with saline1. Cryoablation of intercostal nerves + Sham ESP catheter with saline infusion. |
| ESP + Cryoablation | Experimental | Procedure: Erector spinae plane catheter with 0.5% Ropivacaine2. Cryoablation of intercostal nerves + ESP catheter with local anesthetic infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective mitral valve repair or replacement
- Planned minimally invasive approach
Key exclusion criteria (7 listed)
- Non-English speaking
- Emergency surgery
- Planned or unplanned sternotomy
- Previous history of sternotomy and cardiac surgery
- Allergy to ropivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane catheter with 0.5% RopivacaineUltrasound 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. | Procedure or surgery | ESP + Cryoablation |
| Erector spinae plane catheter with salineAlso: ShamUltrasound 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. | Procedure or surgery | Cryoablation |
Primary outcome
Total opiate consumption
Time frame: 48 hours.
Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record.
8 secondary outcomes
Pain score
Time frame: 48 hours
Time to extubation.
Time frame: Within 30 days from end of operation.
Time to first oral intake
Time frame: Within 30 days from end of operation.
Time to ambulation
Time frame: Within 30 days from end of operation.
Time to chest tube removal
Time frame: Within 30 days from end of operation.
Length of intensive care stay
Time frame: Within 30 days from end of operation.
Length of hospital stay
Time frame: Within 30 days from end of operation.
Patient self-reported experience with surgery and postoperative recovery
Time frame: 30 days after hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson Cui, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane catheter with 0.5% Ropivacaine and Erector spinae plane catheter with saline in people with Mitral Regurgitation and Mitral Valve Insufficiency, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilson Cui, MD, PhD (415-476-6783, Wilson.Cui@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opiate consumption (time frame: 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.