Stellate Ganglion Block | NCT06271707

Studies
Stellate Ganglion Block

NCT06271707

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Sep 4, 2025Actual

Enrollment

48Estimated

Phase

Phase 4

Conditions

Esophagectomy
Pneumonectomy
Lobectomy

Interventions

0.5% bupivacaine
Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2025Actual

Primary Completion Date

Apr 15, 2027Estimated

Completion Date

Jul 15, 2027Estimated

First Submitted Date

Feb 14, 2024

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2025

Last Update Posted Date

Sep 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	ultrasound with bupivacaine	Drug: 0.5% bupivacaine
Group 2	Sham Comparator	Ultrasound with saline	Other: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5% bupivacaine	Drug	an ultrasound guided left stellate ganglion block with 5 mL of 0.5% bupivacaine	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
an ultrasound guided left stellate ganglion block with 5 mL of saline.	Incidence of Atrial fibrillation in the first 168 hours after surgery.	168 hours after surgery
Atrial fibrillation; Other arrhythmias; Adverse events.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Candace Nelson	Contact			nelso377@umn.edu

Overall Officials

Name	Affiliation	Role
Jacob Hutchins	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided