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NCT Number: NCT07570940

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Liposomal bupivacaine

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 1 week

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

Secondary outcomes

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

    Time frame: 1 week

    Duration of postoperative atrial fibrillation episodes will assessed via continuous ECG monitoring and reported in minutes

  2. Number of patients with successful stellate ganglion blockade

    Time frame: 1 week

    Success rate of the stellate ganglion blockade is defined as a ≥1.0°C increase in ipsilateral hand skin temperature from baseline and/or a reduction in skin sympathetic nerve activity (SKNA) as measured by noninvasive surface recordings pre- and post-block.

Study contacts

Contact information is provided by the study sponsor or research team.

Anesthesia Clinical Research Unit (ACRU) Study Team

CONTACT

[email protected]

866-265-9263

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effectiveness Of Liposomal Bupivacaine Stellate Ganglion Blockade In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery: A Randomized Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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