Clinical trial · Interventional
Regional Anesthesia and Breast Cancer Recurrence
NCT00418457CI-TRIAL-00045565completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia and opioids | Drug | — | UNRESOLVED |
| Regional analgesia and propofol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- General anesthesia and opioid
- description
- General anesthesia followed by opioid administration
- interventionNames
- Drug: General anesthesia and opioids
- type
- ACTIVE_COMPARATOR
- label
- Regional analgesia and propofol
- description
- Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
- interventionNames
- Drug: Regional analgesia and propofol
Primary outcomes (1)
- measure
- Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (9)
- DERIVEDLi M, Zhang Y, Pei L, Zhang Z, Tan G, Huang Y. Potential Influence of Anesthetic Interventions on Breast Cancer Early Recurrence According to Estrogen Receptor Expression: A Sub-Study of a Randomized Trial. Front Oncol. 2022 Feb 10;12:837959. doi: 10.3389/fonc.2022.837959. eCollection 2022. PMID 35223519
- DERIVEDAghamelu O, Buggy P, Smith G, Inzitari R, Wall T, Buggy DJ. Serum NETosis expression and recurrence risk after regional or volatile anaesthesia during breast cancer surgery: A pilot, prospective, randomised single-blind clinical trial. Acta Anaesthesiol Scand. 2021 Mar;65(3):313-319. doi: 10.1111/aas.13745. Epub 2020 Nov 29. PMID 33187020
- DERIVEDSessler DI, Pei L, Huang Y, Fleischmann E, Marhofer P, Kurz A, Mayers DB, Meyer-Treschan TA, Grady M, Tan EY, Ayad S, Mascha EJ, Buggy DJ; Breast Cancer Recurrence Collaboration. Recurrence of breast cancer after regional or general anaesthesia: a randomised controlled trial. Lancet. 2019 Nov 16;394(10211):1807-1815. doi: 10.1016/S0140-6736(19)32313-X. Epub 2019 Oct 20. PMID 31645288
- DERIVEDLevins KJ, Prendeville S, Conlon S, Buggy DJ. The effect of anesthetic technique on micro-opioid receptor expression and immune cell infiltration in breast cancer. J Anesth. 2018 Dec;32(6):792-796. doi: 10.1007/s00540-018-2554-0. Epub 2018 Sep 18. PMID 30229370
- DERIVEDKim R. Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle. Cancer Metastasis Rev. 2017 Mar;36(1):159-177. doi: 10.1007/s10555-016-9647-8. PMID 27866303
- DERIVEDPei L, Zhou Y, Tan G, Mao F, Yang D, Guan J, Lin Y, Wang X, Zhang Y, Zhang X, Shen S, Xu Z, Sun Q, Huang Y; Outcomes Research Consortium. Ultrasound-Assisted Thoracic Paravertebral Block Reduces Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer Surgery: A Randomized, Controlled, Single-Center Trial. PLoS One. 2015 Nov 20;10(11):e0142249. doi: 10.1371/journal.pone.0142249. eCollection 2015.