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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
32
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.
University of Minnesota
Minneapolis, Minnesota, United States
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.
Time frame: 5 days
Cumulative Opioid Use - Average Dosages
Outcome reported as the average opioid dosage at 24, 48, 72, 96, and 120 hours post-operatively.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: approximately 7 days
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30-Day Mortality
Outcome reported as the percent of participants in each arm who expire in the 30 days following surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: approximately 5 days
Block performance time
Outcome reported as the length of time (in minutes) for placement of catheters.
Time frame: approximately 1 hour
Duration of vasopressor requirement
Outcome reported as the length of time (in hours) that participants require vasopressor therapy.
Time frame: approximately 24 hours