Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-02 @ 1:31 PM
Study NCT ID:
NCT00418457
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2007-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Regional Anesthesia and Breast Cancer Recurrence
Sponsor:
Organization:
Raw JSON
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Opioid'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sessled@ccf.org', 'phone': '216-444-4900', 'title': 'Daniel Sessler, MD', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'UP to 10 years After surgery', 'eventGroups': [{'id': 'EG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia', 'otherNumAtRisk': 1065, 'deathsNumAtRisk': 1065, 'otherNumAffected': 0, 'seriousNumAtRisk': 1065, 'deathsNumAffected': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia', 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deep sedation or general anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 10 years', 'description': 'time to breast cancer recurrence from the end of surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced Post-Surgical Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '872', 'groupId': 'OG000'}, {'value': '856', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'OG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}], 'classes': [{'title': 'at 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '872', 'groupId': 'OG000'}, {'value': '856', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}]}, {'title': '1-year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months and 1 year', 'description': 'Brief Pain Inventory is used to evaluate with values of any pain vs. no pain (binary)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not available/collected for all participants due to lost follow up or miss phone call.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Experienced Neuropathic Pain After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '859', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'OG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}], 'classes': [{'title': 'at 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '859', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': '1-year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.28', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month and 1 year', 'description': 'neuropathic pain is a binary outcome: any pain vs. no pain', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not available/collected for all participants due to lost follow up or miss phone call.'}, {'type': 'SECONDARY', 'title': 'SF-12 PCS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '807', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'OG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}], 'classes': [{'title': 'at 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': '1-year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '800', 'groupId': 'OG000'}, {'value': '807', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.3', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.014', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.60', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month and 1 year', 'description': 'Physical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not available/collected for all participants due to lost follow up or miss phone call.'}, {'type': 'SECONDARY', 'title': 'SF-12 MCS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '807', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'OG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}], 'classes': [{'title': 'at 6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '800', 'groupId': 'OG000'}, {'value': '807', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': '1-year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.48', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 month and 1 year', 'description': 'Physical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not available/collected for all participants due to lost follow up or miss phone call.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'FG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1065'}, {'groupId': 'FG001', 'numSubjects': '1043'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1065'}, {'groupId': 'FG001', 'numSubjects': '1043'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1065', 'groupId': 'BG000'}, {'value': '1043', 'groupId': 'BG001'}, {'value': '2108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'General Anesthesia and Opioid', 'description': 'General anesthesia followed by opioid administration\n\nGeneral anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia'}, {'id': 'BG001', 'title': 'Regional Analgesia and Propofol', 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol\n\nRegional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '11', 'groupId': 'BG000'}, {'value': '53', 'spread': '12', 'groupId': 'BG001'}, {'value': '53', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1065', 'groupId': 'BG000'}, {'value': '1043', 'groupId': 'BG001'}, {'value': '2108', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '989', 'groupId': 'BG000'}, {'value': '972', 'groupId': 'BG001'}, {'value': '1961', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-14', 'size': 1828452, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-20T11:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2007-01-03', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2007-01-03', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-03', 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery', 'timeFrame': 'up to 10 years', 'description': 'time to breast cancer recurrence from the end of surgery.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Experienced Post-Surgical Pain', 'timeFrame': '6 months and 1 year', 'description': 'Brief Pain Inventory is used to evaluate with values of any pain vs. no pain (binary)'}, {'measure': 'Number of Participants That Experienced Neuropathic Pain After Surgery', 'timeFrame': '6 month and 1 year', 'description': 'neuropathic pain is a binary outcome: any pain vs. no pain'}, {'measure': 'SF-12 PCS Score', 'timeFrame': '6 month and 1 year', 'description': 'Physical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': 'SF-12 MCS Score', 'timeFrame': '6 month and 1 year', 'description': 'Physical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Anesthesia; regional', 'cancer recurrence', 'Anesthesia; inhalational', 'Analgesia; opioid'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '35223519', 'type': 'DERIVED', 'citation': 'Li 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': '33187020', 'type': 'DERIVED', 'citation': 'Aghamelu 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': '31645288', 'type': 'DERIVED', 'citation': 'Sessler 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': '30229370', 'type': 'DERIVED', 'citation': 'Levins 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': '27866303', 'type': 'DERIVED', 'citation': 'Kim 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': '26588217', 'type': 'DERIVED', 'citation': 'Pei 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.'}, {'pmid': '25480319', 'type': 'DERIVED', 'citation': 'Wu J, Buggy D, Fleischmann E, Parra-Sanchez I, Treschan T, Kurz A, Mascha EJ, Sessler DI. Thoracic paravertebral regional anesthesia improves analgesia after breast cancer surgery: a randomized controlled multicentre clinical trial. Can J Anaesth. 2015 Mar;62(3):241-51. doi: 10.1007/s12630-014-0285-8. Epub 2014 Dec 6.'}, {'pmid': '25009197', 'type': 'DERIVED', 'citation': 'Jaura AI, Flood G, Gallagher HC, Buggy DJ. Differential effects of serum from patients administered distinct anaesthetic techniques on apoptosis in breast cancer cells in vitro: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i63-7. doi: 10.1093/bja/aet581. Epub 2014 Jul 9.'}, {'pmid': '25009196', 'type': 'DERIVED', 'citation': 'Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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 disease results in clinical metastases is a function of host defense and tumor survival and growth. At least three perioperative factors shift the balance toward progression of minimal residual disease:\n\n1. Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), increases concentrations of pro-angiogenic factors such as VEGF, and releases growth factors that promote local and distant growth of malignant tissue.\n2. Anesthesia impairs numerous immune functions, including those of neutrophils, macrophages, dendritic cells, T-cell, and natural killer cells.\n3. Opioid analgesics inhibit both cellular and humoral immune function in humans, increase angiogenesis, and promote breast tumor growth in rodents.\n\nHowever, regional analgesia attenuates or prevents each of these adverse effects by largely preventing the neuroendocrine surgical stress response, eliminating or reducing the need for general anesthesia, and minimizing opioid requirement. Animal studies indicate that regional anesthesia and optimum postoperative analgesia independently reduce the metastatic burden in animals inoculated with breast adenocarcinoma cells following surgery. Preliminary data in cancer patients are also consistent: paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis approximately four-fold (95% CI of estimated hazard ratio is 0.71 - 0.06) during a 2.5 to 4-year follow-up period compared to opioid analgesia. The investigators will thus test the hypothesis that recurrence after breast cancer surgery is lower with regional anesthesia/analgesia than with general anesthesia and opioid analgesia.\n\nIn this multi-center trial, Stage 1-3 patients having mastectomies will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and opioid analgesia. As with all time-to-event trials, interim and final analyses are based on the number of outcome events (recurrences in this case) rather than enrollment. The number of patients required is just an estimate and varies based on actual recurrence rates which in turn depend on patients' stage and grade, and ancillary treatments. There will be three evenly spaced interim analyses and a final analysis at 351 recurrences. Confirming our hypothesis will indicate that a minor modification to anesthetic management, one that can be implemented with little risk or cost, will reduce the risk of cancer recurrence - a complication that is often ultimately lethal."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)\n* Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)\n* Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)\n* Written informed consent, including willingness to be randomized to morphine or regional analgesia\n\nExclusion Criteria:\n\n* Previous surgery for breast cancer (except diagnostic biopsies)\n* Inflammatory breast cancer\n* Age \\< 18 or \\> 85 years old\n* Scheduled free flap reconstruction\n* ASA Physical Status ≥ 4\n* Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)\n* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine\n* Other cancer not believed by the attending surgeon to be in long-term remission\n* Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality'}, 'identificationModule': {'nctId': 'NCT00418457', 'briefTitle': 'Regional Anesthesia and Breast Cancer Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Regional Anesthesia and Breast Cancer Recurrence', 'orgStudyIdInfo': {'id': '06-692'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'General anesthesia and opioids', 'type': 'DRUG', 'otherNames': ['General anesthesia'], 'description': 'General anesthesia, usually with sevoflurane, and opioid analgesia', 'armGroupLabels': ['General anesthesia and opioid']}, {'name': 'Regional analgesia and propofol', 'type': 'DRUG', 'otherNames': ['Regional analgesia'], 'description': 'Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia', 'armGroupLabels': ['Regional analgesia and propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University of Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '7', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Daniel I Sessler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'd sessler', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}