Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
Study NCT ID:
NCT02747992
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2016-04-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2016-04-17', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative sedation requirement', 'timeFrame': 'during operation', 'description': 'target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3'}], 'secondaryOutcomes': [{'measure': 'time to first request of analgesics', 'timeFrame': 'postoperative 12 hours'}, {'measure': 'postoperative analgesic requirement', 'timeFrame': 'postoperation to discharge'}, {'measure': 'side effects', 'timeFrame': 'postoperation to within 24 hours after discharge'}]}, 'conditionsModule': {'conditions': ['Mastectomy, Modified Radical']}, 'descriptionModule': {'briefSummary': 'Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The American Society of Anesthesiologists (ASA) Physical Status classification I to III\n* 20 - 75 years of age\n* female gender\n\nExclusion Criteria:\n\n* body mass index (BMI) ≥ 35 kg/m2\n* modified radical mastectomy not performed by the single surgeon (Ben Long Yu)\n* anesthesia not performed by the single anesthesiologist (Nai Liang Li)'}, 'identificationModule': {'nctId': 'NCT02747992', 'briefTitle': 'Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer', 'orgStudyIdInfo': {'id': 'PVBPEC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PECS 0', 'description': 'receiving paravertebral block'}, {'label': 'PECS 1', 'description': 'receiving paravertebral block and blocks targeting pectoral musculature'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Nai Liang Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}