A Study Of Stellate Ganglion Blockade With Liposomal Bupivacaine In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery

NCT07570940 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-009333
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is assess the incidence of postoperative atrial fibrillation (POAF) within one week of surgery in patients who receive pre-surgical stellate ganglion blockade with liposomal bupivacaine, compared to those receiving a saline placebo, using continuous electrocardiographic monitoring via wearable ECG devices.

Conditions

Coronary Artery Disease; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery

  Total number of patients to experience postoperative atrial fibrillation within one week of CABG surgery.

  1 week

Secondary Outcomes (2)

• Total duration of postoperative atrial fibrillation (POAF) episodes within the first postoperative week

  1 week

• Number of patients with successful stellate ganglion blockade

  1 week

Study Arms (2)

Stellate ganglion block using liposomal bupivacaine

EXPERIMENTAL

10 mL of liposomal bupivacaine 133 mg (133 mg/10 ml or 1.33%)

Drug: Liposomal bupivacaine

Sham block using saline placebo

PLACEBO COMPARATOR

10 mL of saline placebo injected in the plane of the right stellate ganglion

Drug: Placebo

Interventions

Liposomal bupivacaine DRUG

Patients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery

Stellate ganglion block using liposomal bupivacaine

Placebo DRUG

Patients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery

Sham block using saline placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥40 years scheduled to undergo isolated coronary artery bypass grafting will be eligible.
• Cases will also remain eligible if, after the initial surgical listing, additional procedures-such as valvular interventions or septal myectomy-are performed, OR if coronary artery bypass grafting (CABG) is listed as the primary intervention with other procedures noted as possible additional interventions.
• Cases will also remain eligible if additional procedures-such as left atrial appendage ligation, MAZE procedure, cryotherapy, or pulmonary vein isolation-are concomitantly listed with the CABG.

You may not qualify if:

• Permanent atrial fibrillation
• Mechanical circulatory support implant or explant
• Procedures not requiring cardiopulmonary bypass
• Heart and/or lung transplant patients
• Active infection/sepsis
• Pre-operative anti-arrhythmic use (aside from beta-blockers).
• Participant has a known allergy to adhesives or hydrogels.
• Participant has a visible skin injury or broken skin at the location for study device placement.
• Participant does not have the competency to wear the device for the prescribed patching period.
• Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
• Participants who are pregnant. In accordance with Mayo Clinic's standard cardiac surgery protocol, all women of childbearing potential undergo routine preoperative pregnancy testing. Pregnancy status will therefore be confirmed prior to enrollment. Any participant with a positive pregnancy test will be deemed ineligible and will not be enrolled in the study.
• Participants who lack the capacity to provide informed consent will not be approached or enrolled in this study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan G. Ripoll Sanz, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anesthesia Clinical Research Unit (ACRU) Study Team

CONTACT

866-265-9263; ripollsanz.juan@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)