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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate ganglion block using liposomal bupivacaine | Experimental | 10 mL of liposomal bupivacaine 133 mg (133 mg/10 ml or 1.33%) |
|
| Sham block using saline placebo | Placebo Comparator | 10 mL of saline placebo injected in the plane of the right stellate ganglion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Patients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery | Total number of patients to experience postoperative atrial fibrillation within one week of CABG surgery. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of postoperative atrial fibrillation (POAF) episodes within the first postoperative week | Duration of postoperative atrial fibrillation episodes will assessed via continuous ECG monitoring and reported in minutes | 1 week |
| Number of patients with successful stellate ganglion blockade |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anesthesia Clinical Research Unit (ACRU) Study Team | Contact | 866-265-9263 | ripollsanz.juan@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Juan G. Ripoll Sanz, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Placebo | Drug | Patients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery |
|
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. |
| 1 week |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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