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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT04019834
Eligibility Criteria:
Inclusion Criteria:
1. Women at least 19 years old who are able to provide written and informed consent
2. Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention
3. Patients with ASA class of I-III will be included
Exclusion Criteria:
1. Stage IV breast cancer, morbid obesity with BMI \>45kg/m2
2. Renal insufficiency (Creatinine \>1.5 mg/dL)
3. Current chronic analgesic use (daily use for \> or equal to 4 weeks)
4. History of opioid abuse or dependence
5. Presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention
6. Incarceration
7. Pregnancy
8. Immediate autologous tissue reconstruction.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT04019834
Study Brief:
Protocol Section:
NCT04019834