SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial

NCT07893275 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 26-700
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation; Postoperative Atrial Fibrillation

Keywords

Cardiac Surgery; Cardiopulmonary bypass; Stellate ganglion block; SG block

Outcome Measures

Primary Outcomes (2)

• Success of treatment

  POAF incidence within the first seven postoperative days

  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

  24 months

Study Arms (2)

Intervention with bupivacaine

ACTIVE COMPARATOR

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

Sham Ganglion Block Normal Saline

PLACEBO COMPARATOR

Patients will receive equivalent volume of normal saline (10mL.)

Drug: Stellate Ganglion Block Injection with 10 mL Normal Saline

Interventions

Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine DRUG

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

Also known as: Active Compator

Intervention with bupivacaine

Stellate Ganglion Block Injection with 10 mL Normal Saline DRUG

Patient will receive 10mL normal saline injection.

Also known as: IV fluids

Sham Ganglion Block Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing cardiac surgery with cardiopulmonary bypass (any: valve ± CABG ± aorta)
• Sinus Rhythm preoperatively

You may not qualify if:

• Preoperative atrial fibrillation or flutter (both paroxysmal and permanent)
• Permanent pacemaker or ICD
• Planned MAZE/PVI, LAAO (LAAO excluded due to effect on risk of POAF)
• Contraindication to regional anesthesia or SGB (infection, coagulopathy, allergy)
• Hemodynamic instability precluding safe SGB
• Circulatory arrest
• Pericardiectomy
• Pulmonary thrombendarterectomy
• Transplants
• VADs
• Percutaneous procedures
• Emergency surgery
• Refusal to participate Percutaneous procedures

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Bupivacaine; Saline Solution; Fluid Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Therapy; Therapeutics

Study Officials

• Marta Kelava, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

2166456928; harbeim@ccf.org

Catalina Dussan, MD, Research Coordinator

CONTACT

2164449950; dussanc@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to received either a left-sided stellate ganglion block with 10 mL of 0.5% preservative-free bupivacaine or a left-sided sham block with an equivalent volume of saline (10 mL).

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 23, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10