Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 6:29 AM
Study NCT ID:
NCT06394960
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Predicting Blood Pressure Change With Interscalene Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change.', 'timeFrame': '60 minute', 'description': 'Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the blood pressure change associated with ISB.'}], 'secondaryOutcomes': [{'measure': 'The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.', 'timeFrame': '60 minute', 'description': 'Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the heart rate change associated with ISB.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interscalene Block', 'Blood Pressure Change', 'Anterior Scalene Muscle Thickness', 'Hypertensive Patient'], 'conditions': ['Systolic Blood Pressure (20% or Greater Increase)']}, 'referencesModule': {'references': [{'pmid': '39972410', 'type': 'DERIVED', 'citation': 'Tutar MS, Polat A, Korkmaz R, Aksoy I, Dogar F, Yildirim A, Satici MH, Yildiz M, Kozanhan B. Prediction of hypertensive responses associated with interscalene block, a prospective cohort study. BMC Anesthesiol. 2025 Feb 19;25(1):82. doi: 10.1186/s12871-025-02947-w.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure', 'detailedDescription': 'This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participating study center will be Konya City Hospital and the research population will consist of volunteer patients who will undergo elective shoulder surgery under interscalene block.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III, elective shoulder surgery will be performed\n\nExclusion Criteria:\n\n* Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease\n* History of chronic opioid or benzodiazepine use\n* Presence of allergy to the local anesthetic drugs used\n* ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).\n* Presence of high level anxiety\n* Patients with a Hospital Anxiety and Depression Scale (HADS) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale'}, 'identificationModule': {'nctId': 'NCT06394960', 'briefTitle': 'Factors Predicting Blood Pressure Change With Interscalene Block', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'Factors Predicting Blood Pressure Change Associated With Interscalene Block, Prospective and Observational Study', 'orgStudyIdInfo': {'id': '13.11.2023-22850'}}, 'contactsLocationsModule': {'locations': [{'zip': '42020', 'city': 'Konya', 'state': 'Karatay', 'country': 'Turkey (Türkiye)', 'facility': 'Konya City Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Anesthesiology and Reanimation', 'investigatorFullName': 'Mahmut Sami TUTAR', 'investigatorAffiliation': 'Konya City Hospital'}}}}