Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-04 @ 7:47 PM
Study NCT ID:
NCT02414256
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2015-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PECS Block in Breast Surgery: an Observational Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Misure', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'Complications Regional Anesthesia Related', 'timeFrame': '1 days'}, {'measure': 'PostOperative Nausea Rate', 'timeFrame': '2 days'}, {'measure': 'Intraoperative Opioids Use', 'timeFrame': 'surgical time'}, {'measure': 'Postoperative Analgesics', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast surgery'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'We will enroll patients submitted to breast surgery (in and outsettings) with regional anesthesia.\n\nThe blinded observers, in the first 48 hours post-operative, will evaluate (telephone interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10 = worst possible pain) thereby recording the treatment procedures in accordance with usual clinical practice. At the same time we will evaluate the presence of intraoperative or postoperative complications related to regional anesthesia, the PONV rate (post-operative nausea and vomiting) and the analgesic/antiemetic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to breast surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA I-II-III Patients Written Informed Consent\n\nExclusion Criteria:\n\nASA IV Active Heart Failure Coagulation Disease Chronic Pain Allergies to Local Anesthetics'}, 'identificationModule': {'nctId': 'NCT02414256', 'briefTitle': 'PECS Block in Breast Surgery: an Observational Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale di Circolo - Fondazione Macchi'}, 'officialTitle': 'PECS Block in Breast Surgery: an Observational Multicenter Study', 'orgStudyIdInfo': {'id': 'Va-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'regional anesthesia in breast surgery', 'type': 'OTHER', 'description': 'In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'state': 'VA', 'country': 'Italy', 'facility': 'Department of Day Surgery Ospedale di Circolo Varese', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Andrea L Ambrosoli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Varese'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale di Circolo - Fondazione Macchi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Luigi Ambrosoli', 'investigatorAffiliation': 'Ospedale di Circolo - Fondazione Macchi'}}}}