A Study Of Stellate Ganglion Blockade With Liposomal Bupivacaine In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07570940
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Atrial Fibrillation
- Coronary Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Liposomal bupivacaine — DRUGPatients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery
- Placebo — DRUGPatients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery
Study Details
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.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2030
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 450 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Stellate ganglion block using liposomal bupivacaine10 mL of liposomal bupivacaine 133 mg (133 mg/10 ml or 1.33%)
- Placebo Comparator: Sham block using saline placebo10 mL of saline placebo injected in the plane of the right stellate ganglion
Primary Outcome Measure
Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery [ Time Frame: 1 week ]
Central Contacts
- Anesthesia Clinical Research Unit (ACRU) Study Team866-265-9263
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
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