Phase 3
Completed N=2,108
Regional Anesthesia and Breast Cancer Recurrence
Source: ClinicalTrials.gov NCT00418457 ↗Enrolled (actual)
2,108
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery — 111; 102 participants — p=0.84
◆ Published Evidence
Highly cited
408citations · ~58 / year
Recurrence of breast cancer after regional or general anaesthesia: a randomised controlled trial.
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.
Linked Publications (5)
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Recurrence of breast cancer after regional or general anaesthesia: a randomised controlled trial.
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Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle.
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The effect of anesthetic technique on µ-opioid receptor expression and immune cell infiltration in breast cancer.
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Potential Influence of Anesthetic Interventions on Breast Cancer Early Recurrence According to Estrogen Receptor Expression: A Sub-Study of a Randomized Trial.
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Serum NETosis expression and recurrence risk after regional or volatile anaesthesia during breast cancer surgery: A pilot, prospective, randomised single-blind clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery |
111; 102 | 0.84 |
| SECONDARY Number of Participants That Experienced Post-Surgical Pain |
456; 442; 232; 239 | 0.70 |
| SECONDARY Number of Participants That Experienced Neuropathic Pain After Surgery |
89; 87; 57; 57 | 0.81 |
| SECONDARY SF-12 PCS Score |
49.7; 49.8; 52.3; 52.1 | 0.96 |
| SECONDARY SF-12 MCS Score |
48.1; 48.7; 48; 48.7 | 0.043 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT00418457) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.