NCT06271707

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
14mo left

Started May 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
May 2025Jul 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

February 14, 2024

Last Update Submit

August 27, 2025

Conditions

EsophagectomyPneumonectomyLobectomy

Keywords

EsophagectomyPneumonectomyLobectomyStellate Ganglion Block

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group 1

EXPERIMENTAL

ultrasound with bupivacaine

Drug: 0.5% bupivacaine

Group 2

SHAM COMPARATOR

Ultrasound with saline

Other: Saline

Interventions

0.5% bupivacaineDRUG

an ultrasound guided left stellate ganglion block with 5 mL of 0.5% bupivacaine

Group 1
SalineOTHER

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

Group 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are pregnant assessed via self-report or pregnancy test if they have taken one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

BupivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jacob Hutchins

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

nelso377@umn.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This is a double blind randomized prospective controlled trial. Randomization will be 1:1.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 22, 2024

Study Start

May 19, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

July 15, 2027

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

US(1)