Stellate Ganglion Block
Left Sided Stellate Ganglion Blocks Impact on the Rate of Post-operative Atrial Fibrillation in Patients Undergoing Thoracic Surgery: A Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Candace Nelson
- Email: nelso377@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Candace Nelson
- Phone Number: 612-626-2465
- Email: nelso377@umn.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group 1
ultrasound with bupivacaine
|
an ultrasound guided left stellate ganglion block with 5 mL of 0.5% bupivacaine
|
|
Sham Comparator: Group 2
Ultrasound with saline
|
an ultrasound guided left stellate ganglion block with 5 mL of saline
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
168 hours after surgery
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jacob Hutchins, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ANES-2024-32720
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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