Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 12:31 PM
Study NCT ID:
NCT03341234
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2017-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-11-09', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': 'First 24 hours total opioid consumption', 'description': 'First 24 hours total fentanyl consumption with patient controlled analgesia'}], 'secondaryOutcomes': [{'measure': 'Visual analog pain score', 'timeFrame': 'postoperative first hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative second hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 4th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 8th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 12th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.'}, {'measure': 'Visual analog pain score', 'timeFrame': 'postoperative 24th hour', 'description': 'Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Superficial Serratus Plane Block', 'Modified Radical Mastectomy', 'Axillary Lymph Node Disection', 'bupivacaine'], 'conditions': ['Postoperative Analgesia', 'Pain, Postoperative', 'Opioid Consumption']}, 'referencesModule': {'references': [{'pmid': '23923989', 'type': 'BACKGROUND', 'citation': 'Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.'}, {'pmid': '28336228', 'type': 'BACKGROUND', 'citation': 'Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.\n\nThe aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection\n\nExclusion Criteria:\n\n* chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications"}, 'identificationModule': {'nctId': 'NCT03341234', 'briefTitle': 'Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Superficial SPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group SPB', 'description': 'Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine', 'interventionNames': ['Drug: Bupivacaine', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Control', 'description': 'Ultrasound guided sham block with 2 ml saline subcutaneously', 'interventionNames': ['Drug: Saline', 'Device: Ultrasound']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '30 ml %0,25 bupivacaine', 'armGroupLabels': ['Group SPB']}, {'name': 'Saline', 'type': 'DRUG', 'description': '2 ml saline subcutaneously', 'armGroupLabels': ['Group Control']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Ultrasound guided block', 'armGroupLabels': ['Group Control', 'Group SPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25070', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Regional Training and Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmet Murat Yayik', 'investigatorAffiliation': 'Ataturk University'}}}}