A Phase 3 interventional study of Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine and Stellate Ganglion Block Injection with 10 mL Normal Saline in Atrial Fibrillation and Postoperative Atrial Fibrillation, sponsored by The Cleveland Clinic. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by The Cleveland Clinic · Phase 3, Interventional, and Prevention
This research study is being conducted to determine whether a stellate ganglion block, a small injection in the neck that temporarily reduces sympathetic nervous system activity, can help reduce the risk of developing postoperative atrial fibrillation after cardiac surgery.
Postoperative atrial fibrillation is a common complication after cardiac surgery and may lead to longer hospital stays and other health problems. This study is also being conducted to evaluate whether this procedure can be performed safely and feasibly in cardiac surgery patients.
The medication used in the active treatment group is bupivacaine, which is approved by the U.S. Food and Drug Administration (FDA). However, its use as part of a stellate ganglion block for prevention of atrial fibrillation after cardiac surgery is considered investigational.
The study procedure will take place after surgery while participants are in the intensive care unit (ICU), before the breathing tube is removed.
If enrolled in the study, participants will receive a single injection in the neck area while still under sedation, using ultrasound guidance, which is a type of imaging that helps the doctor see the area and place the injection safely This procedure is called a stellate ganglion block. The procedure itself takes approximately 10-15 minutes.
Before and after the procedure, the study team will perform simple measurements to assess the effect of the block. These include measuring skin temperature and checking your size. These assessments will take about 10-15 minutes.
Heart rhythm will be monitored as part of standard care during hospital stay. The study team will collect information about development atrial fibrillation within 7 days after surgery.
This study is a prospective, single-center, randomized, triple blinded, placebo-controlled pilot and feasibility trial designed to evaluate the feasibility, safety, and preliminary outcome variance of prophylactic stellate ganglion block in cardiac surgery patients.
This pilot feasibility trial will assess 1) recruitment rate (patients' and surgeons' willingness to participate); 2) optimize procedural success assessment and data collection methods; 3) estimate variability and effect size to ultimately inform the design of a large-scale, high-impact clinical trial evaluating SGB in postoperative cardiac surgery as a prophylactic measure for POAF in high risk POAF patient population.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 60 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Exclusion Criteria:
Participants will receive 10 mL of 0.5% bupivacaine under ultrasound guidance at the C6 level prior to extubation.
Drug: Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine
Patients will receive equivalent volume of normal saline (10mL.)
Drug: Stellate Ganglion Block Injection with 10 mL Normal Saline
Participants will be randomized to receive left-sided stellate ganglion block with 10 mL of 0.5% bupivacaine).
Also known as: Active Compator
Patient will receive 10mL normal saline injection.
Also known as: IV fluids
Success of treatment
POAF incidence within the first seven postoperative days
Time frame: 24months
Study Feasibility
participant recruitment, surgeon engagement, protocol adherence, ability to assess block success in anesthetized patients, and absence of serious adverse events associated with block procedure
Time frame: 24 months
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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