Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT03743194
Eligibility Criteria:
Inclusion Criteria:
1. 18-85 years old;
2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy
Exclusion Criteria:
1. Weight less than 50 kg;
2. Pregnancy or lactation;
3. Emergency surgery and patients transferred from the ICU to the operating room;
4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement);
5. Anticipated endotracheal intubation \> 24 hours;
6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
7. Active systemic or cardiopulmonary infection;
8. Mechanical circulatory support;
9. Allergy or contraindication to study local anesthetics;
10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like Percocet or Vicodin) in a dose of \> 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days;
11. Poorly controlled psychiatric disorders;
12. Clinically important current neurologic deficit;
13. Active liver disease or cirrhosis;
14. Pacemaker generator or breast implants ipsilateral to surgery;
15. Previous participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03743194
Study Brief:
Protocol Section:
NCT03743194