Regional Anesthesia and Breast Cancer Recurrence

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Analgesics, Opioid; Anesthetics; Propofol

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