New Onset Atrial FibrillationPhase 4NCT04472299
Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution in people with New Onset Atrial Fibrillation and Anesthesia, Local, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Onset Atrial Fibrillation, Anesthesia, Local, Cardiac Disease
- What is being tested?
- Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 8 Jul 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG \& surgical valve replacement
Who cannot join
- History of atrial fibrillation or flutter
- Infective endocarditis
- Left ventricular ejection fraction (LVEF) < 30%
- Emergency surgery
- Redo surgery
- Contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic)
- Body mass index > 35kg/m2
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.
Read the detailed description
Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. Patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.
- Being tested
- Ropivacaine 0.2% Injectable Solution
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants in this group will receive the intervention. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Control | No intervention | Participants in this group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New-Onset Atrial Fibrillation (NOAF)
The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.
Measured: 5 days
Secondary outcomes (13)
Cumulative Opioid Use - Average Dosages
Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.
Measured: 24, 48, 72, 96, and 120 hours post-operatively
Cumulative Opioid Use - Morphine Equivalents
Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.
Measured: 24, 48, 72, 96, and 120 hours post-operatively
Time to Extubation
Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.
Measured: approximately 5 days
Intensive Care Unit (ICU) Length of Stay
Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.
Measured: approximately 5 days
Hospital Length of Stay
Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.
Measured: approximately 7 days
30-Day Mortality
Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.
Measured: 30 days
Cumulative ICU sedation doses
Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.
Measured: 24 and 72 hours post-operatively
Diagnosis of delirium during index hospitalization
Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.
Measured: approximately 7 days
Quality of Recovery 15 (QOR-15) Scores
The Quality of Recovery 15 is a 15-item survey evaluating recovery after surgery and anaesthesia. Items are rated on a scale 0-10. Total scores are a sum of item scores and range 0-150, with higher scores representing a higher quality of recovery.
Measured: 24, 48, 72, 96, and 120 hours post-operatively
Average pain score
Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).
Measured: 24, 48, 72, 96, and 120 hours post-operatively
Block-associated complications
Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.
Measured: approximately 5 days
Block performance time
Outcome reported as the length of time (in minutes) for placement of catheters.
Measured: approximately 1 hour
Duration of vasopressor requirement
Outcome reported as the length of time (in hours) that participants require vasopressor therapy.
Measured: approximately 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Apr 2021
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Onset Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Flaherty, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472299
- Sponsor's protocol ID
- ANES-2020-28859
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2020
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04472299
- Acronym / sponsor ID
- ANES-2020-28859
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 15 Jul 2020 (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 purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.
Detailed description
Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. Patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Ropivacaine 0.2% Injectable SolutionParticipants in this group will receive the intervention. |
| Control | No intervention | –Participants in this group will receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG \& surgical valve replacement
Key exclusion criteria (8 listed)
- History of atrial fibrillation or flutter
- Infective endocarditis
- Left ventricular ejection fraction (LVEF) < 30%
- Emergency surgery
- Redo surgery
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionPatients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. | Drug | Experimental |
Primary outcome
Incidence of New-Onset Atrial Fibrillation (NOAF)
Time frame: 5 days
The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.
13 secondary outcomes
Cumulative Opioid Use - Average Dosages
Time frame: 24, 48, 72, 96, and 120 hours post-operatively
Cumulative Opioid Use - Morphine Equivalents
Time frame: 24, 48, 72, 96, and 120 hours post-operatively
Time to Extubation
Time frame: approximately 5 days
Intensive Care Unit (ICU) Length of Stay
Time frame: approximately 5 days
Hospital Length of Stay
Time frame: approximately 7 days
30-Day Mortality
Time frame: 30 days
Cumulative ICU sedation doses
Time frame: 24 and 72 hours post-operatively
Diagnosis of delirium during index hospitalization
Time frame: approximately 7 days
Quality of Recovery 15 (QOR-15) Scores
Time frame: 24, 48, 72, 96, and 120 hours post-operatively
Average pain score
Time frame: 24, 48, 72, 96, and 120 hours post-operatively
Block-associated complications
Time frame: approximately 5 days
Block performance time
Time frame: approximately 1 hour
Duration of vasopressor requirement
Time frame: approximately 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
James Flaherty, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution in people with New Onset Atrial Fibrillation and Anesthesia, Local, run by University of Minnesota 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 5 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Atrial Fibrillation (NOAF) (time frame: 5 days). 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 5 Aug 2025.