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Completed

NCT Number: NCT04472299

Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery

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.

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Key information

Conditions

New Onset Atrial Fibrillation Anesthesia, Local Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.2% Injectable Solution

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cumulative Opioid Use - Average Dosages

    Time frame: 24, 48, 72, 96, and 120 hours post-operatively

    Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.

  2. Cumulative Opioid Use - Morphine Equivalents

    Time frame: 24, 48, 72, 96, and 120 hours post-operatively

    Outcome reported as the cumulative opioid use in morphine milligram equivalents at 24, 48, 72, 96, and 120 hours post-operatively.

  3. Time to Extubation

    Time frame: approximately 5 days

    Outcome reported as the amount of time (in hours) participants remain intubated post-operatively.

  4. Intensive Care Unit (ICU) Length of Stay

    Time frame: approximately 5 days

    Outcome reported as the length of time (in days) that participants are admitted to the intensive care unit (ICU) post-operatively.

  5. Hospital Length of Stay

    Time frame: approximately 7 days

    Outcome reported as the length of time (in days) that participants remain admitted to the hospital post-operatively.

  6. 30-Day Mortality

    Time frame: 30 days

    Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.

  7. Cumulative ICU sedation doses

    Time frame: 24 and 72 hours post-operatively

    Outcome reported as the cumulative doses of sedatives (Midazolam, Fentanyl, Propofol, Dexmedetomidine, Haloperidol, Olanzapine) at 24 hours and 72 hours post-operatively.

  8. Diagnosis of delirium during index hospitalization

    Time frame: approximately 7 days

    Outcome reported as the percent of participants in each arm who are diagnosed with delirium during hospital admission.

  9. Quality of Recovery 15 (QOR-15) Scores

    Time frame: 24, 48, 72, 96, and 120 hours post-operatively

    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.

  10. Average pain score

    Time frame: 24, 48, 72, 96, and 120 hours post-operatively

    Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (maximum pain imaginable).

  11. Block-associated complications

    Time frame: approximately 5 days

    Outcome reported as the number of block-associated complications including catheter infection, vascular puncture, bleeding that results in neurologic compromise, pneumothorax.

  12. Block performance time

    Time frame: approximately 1 hour

    Outcome reported as the length of time (in minutes) for placement of catheters.

  13. Duration of vasopressor requirement

    Time frame: approximately 24 hours

    Outcome reported as the length of time (in hours) that participants require vasopressor therapy.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2020
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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