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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00418457
Eligibility Criteria:
Inclusion Criteria:
* Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
* Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
* Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
* Written informed consent, including willingness to be randomized to morphine or regional analgesia
Exclusion Criteria:
* Previous surgery for breast cancer (except diagnostic biopsies)
* Inflammatory breast cancer
* Age \< 18 or \> 85 years old
* Scheduled free flap reconstruction
* ASA Physical Status ≥ 4
* Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
* Other cancer not believed by the attending surgeon to be in long-term remission
* Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00418457
Study Brief:
Protocol Section:
NCT00418457