Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 5:15 PM
Study NCT ID:
NCT05852561
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative opioid consumption', 'timeFrame': 'first 24 hours', 'description': 'First 24 hours total fentanyl consumption with patient controlled analgesia'}], 'secondaryOutcomes': [{'measure': 'Visual analog pain score', 'timeFrame': 'first 48 hours', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '31045789', 'type': 'BACKGROUND', 'citation': 'Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.'}, {'pmid': '33546068', 'type': 'BACKGROUND', 'citation': 'Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.'}]}, 'descriptionModule': {'briefSummary': 'Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.\n\nThe aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. American Society of Anesthesiologist's physiologic state I-III patients\n2. To undergo Video Assisted Thoracic Surgery\n3. Being between the ages of 18-65 years\n\nExclusion Criteria:\n\n* having a known heart, kidney, liver or hematological disease\n* having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain\n* Routine analgesic use and history of analgesic use in the last 24 hours\n* Not willingto participate in the study\n* Uncooperative patients who have coagulopathy or use anticoagulant drugs\n* To be allergic to one of the drugs to be used\n* Contraindication for Video Assisted Thoracic Surgery"}, 'identificationModule': {'nctId': 'NCT05852561', 'briefTitle': 'Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery', 'orgStudyIdInfo': {'id': 'ataunivatsanalgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Superficial+Deep Serratus Anterior Plan Block', 'description': 'Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery', 'interventionNames': ['Other: Group Superficial+Deep Serratus Anterior Plan Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Deep Serratus Anterior Plan Block', 'description': 'Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery', 'interventionNames': ['Other: Group Deep Serratus Anterior Plan Block']}], 'interventions': [{'name': 'Group Superficial+Deep Serratus Anterior Plan Block', 'type': 'OTHER', 'description': 'The block will be performed after induction of general anesthesia and surgical positioning. 15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles. The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle.', 'armGroupLabels': ['Group Superficial+Deep Serratus Anterior Plan Block']}, {'name': 'Group Deep Serratus Anterior Plan Block', 'type': 'OTHER', 'description': '30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle.', 'armGroupLabels': ['Group Deep Serratus Anterior Plan Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ali Ahiskalioglu', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Elif Oral Ahiskalioglu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elif Oral Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}