Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-01 @ 11:18 PM
Study NCT ID:
NCT03992859
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2018-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Serrates Plane Block in Axillary Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '12-48 hours', 'description': 'A 70% reduction in morphine consumption in the continuous serratus plane block over control'}], 'secondaryOutcomes': [{'measure': 'persistent post-surgical pain: numerical rating scale', 'timeFrame': '3-6 months', 'description': 'a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),\\> 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.', 'detailedDescription': '84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* breast surgery\n* informed consent\n\nExclusion Criteria:\n\n* ASA \\>3\n* allergy to local anesthetic\n* opioid administration in the last month\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT03992859', 'briefTitle': 'Continuous Serrates Plane Block in Axillary Dissection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Continuous Serratus Plane Block Added to PECS II vs PECS II Alone for Post Operative Analgesia After Axillary Dissection in Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'CIMPAX BREAST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'serratus catheter', 'description': 'Continuous serratus plane block: Ropivacaine 0.2% infusion through a multiple hole catheter (C-Cat Cimpax Denmark)at a fixed dose of 12 ml/h and a multimodal analgesia with acetaminophen and a PCA of morphine', 'interventionNames': ['Procedure: Continuous serratus plane block']}, {'type': 'NO_INTERVENTION', 'label': 'standard treatment', 'description': 'Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine'}], 'interventions': [{'name': 'Continuous serratus plane block', 'type': 'PROCEDURE', 'description': 'Peripheral nerve catheter placed by the surgeon at the end of surgery', 'armGroupLabels': ['serratus catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42120', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Ausl-Irccs Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Giorgio Francesco Danelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Reggio Emilia - IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}