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Clinical Trials/NCT06271707
NCT06271707
Recruiting
Phase 4

Left Sided Stellate Ganglion Blocks Impact on the Rate of Post-operative Atrial Fibrillation in Patients Undergoing Thoracic Surgery: A Pilot Study

University of Minnesota1 site in 1 country48 target enrollmentStarted: May 19, 2025Last updated:

Overview

Phase
Phase 4
Status
Recruiting
Enrollment
48
Locations
1
Primary Endpoint
an ultrasound guided left stellate ganglion block with 5 mL of saline.

Overview

Brief Summary

The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

This is a double blind randomized prospective controlled trial. Randomization will be 1:1.

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing esophagectomy, pneumonectomy, or lobectomy aged 18-85.

Exclusion Criteria

  • Patients who have an exclusion to regional anesthesia.
  • Patients who have exclusion to stellate blockade.
  • Patients who are pregnant assessed via self-report or pregnancy test if they have taken one

Arms & Interventions

Group 1

Experimental

ultrasound with bupivacaine

Intervention: 0.5% bupivacaine (Drug)

Group 2

Sham Comparator

Ultrasound with saline

Intervention: Saline (Other)

Outcomes

Primary Outcomes

an ultrasound guided left stellate ganglion block with 5 mL of saline.

Time Frame: 168 hours after surgery

Incidence of Atrial fibrillation in the first 168 hours after surgery.

Atrial fibrillation; Other arrhythmias; Adverse events.

Time Frame: 168 hours after surgery

Atrial fibrillation in first 24, 48, 72, 96, 120, and 144 hours; Other arrhythmias in first 24, 48, 72, 96, 120, 144 and 168 hours; Adverse events.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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