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NOT YET RECRUITING
NCT07893275
PHASE3

SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

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.

Official title: Stellate Ganglion Block for the Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery-Pilot & Feasibility Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10-15

Completion Date

2027-11

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine

Participants will be randomized to receive left-sided stellate ganglion block with 10 mL of 0.5% bupivacaine).

DRUG

Stellate Ganglion Block Injection with 10 mL Normal Saline

Patient will receive 10mL normal saline injection.