Atrial FibrillationNCT02784587
Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery
A study testing Stellate Ganglion Block in people with Atrial Fibrillation, run by Christopher Connors, MD.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2016to 7 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for AVR, CABG, or CABG/AVR
Who cannot join
- 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
About this study
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.
Read more
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.
Read the detailed description
Patients at MMC undergoing transapical transcatheter aortic valve replacement (TA TAVR) routinely receive a paravertebral block for analgesia. This has the added benefit of providing a unilateral sympathectomy which may be analogous to a stellate ganglion block, albeit via a different technique. In a recent retrospective chart review, TA TAVR block patients showed a decreased rate of new onset POAF. Furthermore, when studying whether pre-emptive stellate ganglion block increases the patency of radial artery grafts in coronary bypass surgery, researchers found a statistically significant decrease (p = 0.048) in atrial fibrillation and the use of anti-arrhythmic agents. Unfortunately, this was a secondary outcome in a small patient population and, while suggestive, the study was not sufficiently powered to draw a definitive conclusion. Importantly, however, they reported no complications related to the block in the fifty patients who received an intervention. Lastly, an additional study demonstrated the safety and feasibility of stellate ganglion mapping and ablation during CABG while also suggesting a clinically significant effect on POAF, but used a permanent, technically complex and time intensive procedure.
The investigator's hypothesis is that perioperative SGB in cardiac surgery is clinically efficient and efficacious. To address this, the investigator will:
- Recruit 49 patients to undergo perioperative SGB during prior to cardiac surgery (CABG, CABG/Aortic Valve Replacement, Aortic Valve Replacement).
- Monitor the safety of SGB using post procedure surface ultrasound of the neck and active solicitation on Post-op Day (POD) 0 and 1 for identified complications, in addition to routine clinical monitoring.
- Assess clinical feasibility of SGB by measuring procedural efficacy and efficiency:
- Efficacy will be measured using post procedure hand temperature; success is indicated by an increase greater than 1 degree Celsius.
- Efficiency will be measured as the time to complete the block and the time added to the standard anesthesia induction sequence, as a proportion of total time in the operating room.
Significance: If the investigator is able to demonstrate that perioperative SGB in cardiac surgery is safe and clinically feasible, the next step will be to design a study to investigate the effect of SGB on POAF incidence (and thereby its attendant morbidity, mortality and costs) in this clinical population.
- Conditions
- Atrial Fibrillation
- Being tested
- Stellate Ganglion Block
- Keywords
- stellate ganglion block, cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day of surgery
Secondary outcomes (1)
Rate of Atrial Fibrillation
The current rate of atrial fibrillation is measured by the Northern New England Cardiac Database, this existing database will track a-fib rates until the patients are discharged from the hospital after surgery.
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start31 May 2016
- Primary completion6 Dec 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Connors, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Connors, MD, MaineHealth
- Investigators
- Christopher Connors, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784587
- Sponsor's protocol ID
- #4624
- Status last verified
- Apr 2019
- First submitted
- 17 May 2016
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02784587
- Acronym / sponsor ID
- #4624
- Conditions
- Atrial Fibrillation
- Keywords
- stellate ganglion block, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Christopher Connors, MDUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients at MMC undergoing transapical transcatheter aortic valve replacement (TA TAVR) routinely receive a paravertebral block for analgesia. This has the added benefit of providing a unilateral sympathectomy which may be analogous to a stellate ganglion block, albeit via a different technique. In a recent retrospective chart review, TA TAVR block patients showed a decreased rate of new onset POAF. Furthermore, when studying whether pre-emptive stellate ganglion block increases the patency of radial artery grafts in coronary bypass surgery, researchers found a statistically significant decrease (p = 0.048) in atrial fibrillation and the use of anti-arrhythmic agents. Unfortunately, this was a secondary outcome in a small patient population and, while suggestive, the study was not sufficiently powered to draw a definitive conclusion. Importantly, however, they reported no complications related to the block in the fifty patients who received an intervention. Lastly, an additional study demonstrated the safety and feasibility of stellate ganglion mapping and ablation during CABG while also suggesting a clinically significant effect on POAF, but used a permanent, technically complex and time intensive procedure.
The investigator's hypothesis is that perioperative SGB in cardiac surgery is clinically efficient and efficacious. To address this, the investigator will:
- Recruit 49 patients to undergo perioperative SGB during prior to cardiac surgery (CABG, CABG/Aortic Valve Replacement, Aortic Valve Replacement).
- Monitor the safety of SGB using post procedure surface ultrasound of the neck and active solicitation on Post-op Day (POD) 0 and 1 for identified complications, in addition to routine clinical monitoring.
- Assess clinical feasibility of SGB by measuring procedural efficacy and efficiency:
- Efficacy will be measured using post procedure hand temperature; success is indicated by an increase greater than 1 degree Celsius.
- Efficiency will be measured as the time to complete the block and the time added to the standard anesthesia induction sequence, as a proportion of total time in the operating room.
Significance: If the investigator is able to demonstrate that perioperative SGB in cardiac surgery is safe and clinically feasible, the next step will be to design a study to investigate the effect of SGB on POAF incidence (and thereby its attendant morbidity, mortality and costs) in this clinical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block | Experimental | Procedure: Stellate Ganglion BlockAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for AVR, CABG, or CABG/AVR
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockAfter 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. | Procedure or surgery | Stellate Ganglion Block |
Primary outcome
Success of Stellate Ganglion Block
Time frame: day of surgery
Correct placement of stellate ganglion block as measured by a temperature rise of at least 1 degree Celsius in the ipsilateral hand
1 secondary outcome
Rate of Atrial Fibrillation
Time frame: Through study completion, approximately 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Connors, MD principal investigator
MaineHealth
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block in people with Atrial Fibrillation, run by Christopher Connors, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Stellate Ganglion Block (time frame: day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.