Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT05648266
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serratus Plane Block After Minimally Invasive Mitral Valve Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of Numeric Rating Scale after MIC-MKR', 'timeFrame': 'within 12, 24 and 48 hours after surgery', 'description': 'Numeric Rating Scale (0-10, 0=smallest value, 10=greatest value)'}], 'secondaryOutcomes': [{'measure': 'Difference of opioid consumption after MIC-MVR', 'timeFrame': 'within 12, 24 and 48 hours after surgery', 'description': 'daily, cumulative dose of opioid analgetic medication after MIC-MKR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Minimal Invasive Cardiac Surgery', 'Minimal Invasive Cardiac Surgery Mitral Valve Surgery', 'Serratus Anterior Plane Block']}, 'descriptionModule': {'briefSummary': 'Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.\n\nThe intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.\n\nThe control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Planned minimal invasive mitral valve repair via right anterior thoracotomy\n\nExclusion Criteria:\n\n* Pregenancy\n* Opioid abuse\n* Historyof chronic pain\n* Allergy to local anaesthetics (in this case ropivacain)\n* Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure'}, 'identificationModule': {'nctId': 'NCT05648266', 'briefTitle': 'Serratus Plane Block After Minimally Invasive Mitral Valve Repair', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Serratus Plane Block After Minimally Invasive Mitral Valve Repair', 'orgStudyIdInfo': {'id': '19518181202119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous SAPB', 'description': 'postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)', 'interventionNames': ['Drug: Continous SAPB (Ropivacain)', 'Other: institutional standard of care pain medication protocol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'standard of care', 'interventionNames': ['Other: institutional standard of care pain medication protocol']}], 'interventions': [{'name': 'Continous SAPB (Ropivacain)', 'type': 'DRUG', 'description': 'postoperative SAPB and pain catheter with continous administered (5ml/h Ropivacain 0,2%) for 48h', 'armGroupLabels': ['Continuous SAPB']}, {'name': 'institutional standard of care pain medication protocol', 'type': 'OTHER', 'description': 'institutional standard of care pain medication protocol', 'armGroupLabels': ['Continuous SAPB', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'University Hospital Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}