A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05357690
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief Summary

The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Stellate ganglion block; Drug: Bupivacaine; Drug: Placebo	Phase 2/Phase 3

Detailed Description

We hypothesize that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (POAF).

Specific Aim 1: Determine the incidence of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 2: Determine the duration of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 3: Determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (SKNA).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stellate ganglion block with local anesthetic Subjects will receive a single injection of bupivacaine in a stellate ganglion block	Procedure: Stellate ganglion block; Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.; Drug: Bupivacaine; 10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion
Sham Comparator: Stellate ganglion block with saline placebo Subjects will receive a single injection of saline in a stellate ganglion block	Procedure: Stellate ganglion block; Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.; Drug: Placebo; 10 mL of saline injected in the plane of the right stellate ganglion

Outcome Measures

Primary Outcome Measures

1. Incidence of atrial fibrillation [Within one week of surgery or during hospitalization if discharged prior to one week]

   Percentage of subjects to experience postoperative atrial fibrillation (POAF)

Secondary Outcome Measures

1. Duration of atrial fibrillation [Within one week of surgery or during hospitalization if discharged prior to one week]

   Duration of postoperative atrial fibrillation (POAF)

2. Skin Sympathetic Nerve Activity [10-30 minute following performance of nerve block]

   Measurement of difference in skin sympathetic nerve activity following block

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.

• Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.

Exclusion Criteria:

• Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.

• Patients with procedures not requiring cardiopulmonary bypass.

• Patients with procedures requiring deep hypothermic circulatory arrest.

• Patients with active infection or sepsis.

• Pre-operative immunosuppressive medication use (including steroid use).

• Pre-operative anti-arrhythmic medication use (aside from beta-blockers).

• Patients with Immunodeficiency syndrome.

• Patients with known neurologic disorder.

• Patients requiring left internal jugular central line placement.

• Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Erica Wittwer, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Erica D. Wittwer, M.D., Ph.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05357690
• Other Study ID Numbers: 22-001106
• First Posted: May 3, 2022
• Last Update Posted: May 3, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Bupivacaine

Study Results

No Results Posted as of May 3, 2022