Using a paravertebral block to prevent new atrial fibrillation after heart surgery
Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
This study is testing if a special pain relief method using a local anesthetic can help prevent new heart rhythm problems in patients having heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04472299 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate whether a perioperative infusion of 0.2% ropivacaine through bilateral T3 paravertebral catheters can reduce the occurrence of new onset atrial fibrillation in patients undergoing primary coronary artery bypass grafting (CABG) or valve surgery. Patients in the intervention group will receive ultrasound-guided catheter placement and a local anesthetic infusion during and after surgery, while the control group will receive standard anesthetic care without the block. The study will also assess various secondary outcomes related to the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective or urgent primary CABG or valve surgeries.
Not a fit: Patients with a history of atrial fibrillation, emergency surgeries, or contraindications to block placement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of new onset atrial fibrillation in patients undergoing cardiac surgery.
How similar studies have performed: Other studies have explored similar anesthetic techniques, but this specific approach is novel in the context of preventing atrial fibrillation after cardiac surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 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 Exclusion Criteria: * 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: James Flaherty, MD — University of Minnesota
- Study coordinator: Candace Nelson
- Email: nelso377@umn.edu
- Phone: 612-626-2465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.