Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 10:28 AM
Study NCT ID:
NCT03177733
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2017-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative morphine consumption until 72 hours after the surgery.', 'timeFrame': '3 days', 'description': 'The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain levels during the first 72 hours.', 'timeFrame': '3 days', 'description': 'Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.'}, {'measure': 'Level of comfort during the first 72 hours', 'timeFrame': '3 days', 'description': 'level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast surgery', 'acute pain', 'regional anesthesia'], 'conditions': ['Mastectomy']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.\n\nTo obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.', 'detailedDescription': "Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.\n\nPeripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).\n\nCurrently in our hospital in every day's practice, we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.\n\nThis technique was described by Fajardo et al. They evoked the possibility of the association serratus and PIF blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made.\n\nThe objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.\n\nThis is a purely observational study that assesses our current practice in this type of surgery.\n\nwe already included a patient series but the clinical trial registration was made to late to do it correctly. To obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients included in the study have had a total mastectomy surgery with a complete axillary lymph nodes removal.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* total mastectomy surgery with a complete axillary lymph nodes removal\n\nExclusion Criteria:\n\n* age under 18\n* contraindication to the surgery\n* refusal of the protocol by the patient'}, 'identificationModule': {'nctId': 'NCT03177733', 'briefTitle': 'Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Maison de Santé Prostestante de Bordeaux Bagatelle'}, 'officialTitle': 'Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery', 'orgStudyIdInfo': {'id': 'Evaluation of breast biblock 2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Evaluation of a breast double block', 'type': 'PROCEDURE', 'description': 'we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.\n\nThe objective is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.\n\nThis is a purely observational study that assesses our current practice in this type of surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33401', 'city': 'Talence', 'state': 'Aquitaine', 'country': 'France', 'facility': 'Maison de Santé Protestante de Bordeaux-Bagatelle', 'geoPoint': {'lat': 44.80849, 'lon': -0.58915}}], 'overallOfficials': [{'name': 'Claude-charles Balick-weber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maison de Santé Protestante de Bordeaux-Bagatelle'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maison de Santé Prostestante de Bordeaux Bagatelle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Claude-Charles Balick-Weber', 'investigatorAffiliation': 'Maison de Santé Prostestante de Bordeaux Bagatelle'}}}}