Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery

NCT02784587 | Completed Results DMC

• 1 other identifier: #4624
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Keywords

stellate ganglion block; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Success of Stellate Ganglion Block

  Correct placement of stellate ganglion block as measured by a temperature rise of at least 1 degree Celsius in the ipsilateral hand

  day of surgery

Secondary Outcomes (1)

• Rate of Atrial Fibrillation

  Through study completion, approximately 1 year

Study Arms (1)

Stellate Ganglion Block

EXPERIMENTAL

All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.

Procedure: Stellate Ganglion Block

Interventions

Stellate Ganglion Block PROCEDURE

After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection. A negative aspiration test will be performed in two planes before a 1-ml test dose is used to exclude unintentional intravascular injection (vertebral or subclavian arteries) or subarachnoid injection into the dural sleeve.4 A total of 10 ml of 0.25% bupivacaine will be injected.

Stellate Ganglion Block

Eligibility Criteria

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

You may qualify if:

• scheduled for AVR, CABG, or CABG/AVR

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Connors, MD: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research coordinator
• Organization: Maine Medical Center

richaj3@mmc.org

2076622862

Study Officials

• Christopher Connors, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 27, 2016
• Study Start: May 31, 2016
• Primary Completion: December 6, 2016
• Study Completion: December 7, 2016
• Last Updated: July 8, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-04