Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:11 AM
Study NCT ID:
NCT07401602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Strategies After Mastectomy: RIB vs RIB + DPIPB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Score (VAS)', 'timeFrame': 'Within the first 24 hours after surgery (postoperative 1, 6, 12, and 24 hours).', 'description': 'Postoperative pain intensity assessed using the Visual Analog Scale (VAS) based on routinely recorded clinical data.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '39304815', 'type': 'RESULT', 'citation': 'Ertas G, Cakmak HS, Ocak S, Yilmaz M, Ozdemir DB, Tulgar S. Is the combination of interfascial plane blocks sufficient for awake breast cancer surgery? An observational, prospective, proof-of-concept study. BMC Anesthesiol. 2024 Sep 20;24(1):337. doi: 10.1186/s12871-024-02725-0.'}, {'pmid': '39453840', 'type': 'RESULT', 'citation': 'Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective observational study evaluates postoperative pain outcomes in patients undergoing elective mastectomy who received systemic analgesia, rhomboid intercostal block (RIB), or combined rhomboid intercostal block with deep parasternal intercostal plane block (RIB + DPIPB). Medical records from October 2024 to October 2025 will be reviewed. Primary outcomes include pain scores within the first 24 hours, with secondary outcomes including opioid consumption, additional analgesic requirements, patient satisfaction, and early postoperative complications. All data will be analyzed retrospectively and anonymously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult female patients aged 18-70 years who underwent elective mastectomy at a single tertiary care center between October 2024 and October 2025 and had complete postoperative pain and analgesia records available for retrospective analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18-70 years\n* Elective mastectomy performed between October 2024 and October 2025\n* ASA physical status I-III\n* Complete postoperative pain and analgesia records for the first 24 hours\n* Clearly documented analgesic technique (systemic analgesia, RIB, or RIB + DPIPB)\n\nExclusion Criteria:\n\n* Incomplete or missing medical records\n* Emergency mastectomy or emergency surgery\n* Reoperation within the first 24 hours postoperatively\n* Major intraoperative complications preventing standard analgesia\n* Neurological or psychiatric conditions interfering with pain assessment'}, 'identificationModule': {'nctId': 'NCT07401602', 'briefTitle': 'Analgesic Strategies After Mastectomy: RIB vs RIB + DPIPB', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'A Retrospective Evaluation of Systemic Analgesia, Rhomboid Intercostal Block, and Combined Rhomboid Intercostal Block With Deep Parasternal Intercostal Plane Block After Mastectomy', 'orgStudyIdInfo': {'id': 'zeki mastektomi'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systemic Analgesia Group', 'interventionNames': ['Other: Analgesic Strategy']}, {'label': 'Rhomboid Intercostal Block (RIB) Group', 'interventionNames': ['Other: Analgesic Strategy']}, {'label': 'RIB + Deep Parasternal Intercostal Plane Block (DPIPB) Group', 'interventionNames': ['Other: Analgesic Strategy']}], 'interventions': [{'name': 'Analgesic Strategy', 'type': 'OTHER', 'description': 'Systemic Analgesia:\n\nPostoperative pain was managed using standard systemic analgesic medications as part of routine clinical care.\n\nRhomboid Intercostal Block (RIB):\n\nPostoperative analgesia was provided using an ultrasound-guided rhomboid intercostal block performed as part of routine clinical practice.\n\nRIB + Deep Parasternal Intercostal Plane Block (DPIPB):\n\nPostoperative analgesia was provided using a combination of ultrasound-guided rhomboid intercostal block and deep parasternal intercostal plane block as part of routine clinical care.', 'armGroupLabels': ['RIB + Deep Parasternal Intercostal Plane Block (DPIPB) Group', 'Rhomboid Intercostal Block (RIB) Group', 'Systemic Analgesia Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'state': 'Merkez Mahallesi', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye Üniversity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ilke Dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Istinye University'}}}}