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:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT04440995
Eligibility Criteria:
Inclusion Criteria:
1. 20years or older
2. Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction
3. American Society of Anesthesiologists(ASA) physical status I and III
Exclusion Criteria:
1. Emergency operation
2. Reoperation
3. Patients with local anesthetic allergy
4. Patients with coagulopathy
5. Patients on anticoagulants
6. Patients who cannot use patient controlled analgesia(PCA)
7. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\]
8. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM
9. Patients with history of heart failure (unstable angina, congestive heart failure)
10. Patients with history of liver failure, renal failure, allergic to medicine
11. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
13. Patients who cannot read the consent form (examples: Illiterate, foreigner)
14. Patients who withdraw the consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04440995
Study Brief:
Protocol Section:
NCT04440995