Status:
COMPLETED
Regional Anesthesia and Breast Cancer Recurrence
Lead Sponsor:
The Cleveland Clinic
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
Brief 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/analg...
Detailed Description
Surgery is the primary and most effective treatment of breast cancer, but residual disease in the form of scattered micrometastases and tumor cells are usually unavoidable. Whether minimal residual di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
2108 Patients enrolled
Trial Details
Trial ID
NCT00418457
Start Date
January 1 2007
End Date
December 1 2019
Last Update
June 16 2020
Active Locations (6)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
Medical University of Vienna
Vienna, Austria
3
Peking Union Medical College Hospital
Beijing, China
4
University of Düsseldorf
Düsseldorf, Germany, 40225