N/A
N=25
Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02784587 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Success of Stellate Ganglion Block — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stellate Ganglion Block (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Connors, MD
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Stellate Ganglion Block |
22 | — |
| SECONDARY Rate of Atrial Fibrillation |
— | — |
Summary
Based upon Northern New England Cardiovascular Study Group data, the rate of post operative atrial fibrillation (POAF) requiring treatment following coronary artery bypass grafting (CABG) at Maine Medical Center (MMC) is currently 30%. Nationally, POAF occurs in up to 40% of patients post CABG, 50% of patients after valve surgery, 64% of patients post mitral valve and CABG and 49% after aortic valve replacement. Atrial fibrillation worsens a patient's hemodynamic status and increases the risk of congestive heart failure (CHF), embolic events and longer ICU stays leading to increased patient morbidity and strain on financial resources. In the U.S., POAF carries a higher risk of stroke (37% OR 2.0 in-hospital mortality (OR = 1.7), worsened survival (74% versus 87%), and an additional 4.9 days and $10,000-$11,500 in hospital stay costs.
Atrial fibrillation requires both an initiation trigger and favorable environment for maintenance and the sympathetic and parasympathetic nervous systems play important roles in this regard. Unfortunately, the precise mechanisms of POAF are still being investigated. This postoperative complication has persisted in spite of efforts to mitigate it pharmacologically with beta blockers and amiodarone, an experience shared by most other cardiac surgery centers.
The stellate ganglion is formed by the fusion of the inferior cervical sympathetic ganglion and first thoracic sympathetic ganglion. By modulating the sympathetic component of the autonomic nervous system, stellate ganglion stimulation has been shown to facilitate induction of atrial fibrillation while ablation may reduce or prevent episodes. Human studies have further supported this model.
Preliminary studies of perioperative stellate ganglion block (SGB) in cardiac surgery suggest that this technique may reduce or prevent episodes of POAF requiring treatment. The investigator's ultimate goal is to determine whether SGB reduces the incidence of POAF in specific cardiac surgery populations at MMC. First, however, the investigator proposes to test the hypothesis that SGB, performed perioperatively by cardiac anesthesiologists in a population of patients undergoing cardiac surgery, is both safe and clinically feasible.
Eligibility Criteria
Inclusion Criteria
- scheduled for AVR, CABG, or CABG/AVR
Exclusion Criteria
- age <18 years
- pregnant women
- prisoners
- patients having emergency surgery
- patients with any clinical contraindication to SGB, including: amide local anesthetic allergy or hypersensitivity, carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies
- patients with severe chronic obstructive pulmonary disease as defined by the need for home oxygen
- patients who do not speak or write English or are unable to give informed consent
- patients with a history of atrial fibrillation
Data sourced from ClinicalTrials.gov (NCT02784587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.