Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT01185457
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2010-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Interscalene Block on Heart Rate Variability (HRV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of interscalene block on Heart Rate Variability (HRV)', 'timeFrame': '1 year', 'description': "The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right."}], 'secondaryOutcomes': [{'measure': 'Interscalene block and beach chair positioning', 'timeFrame': '2 years', 'description': 'Effect of interscalene block on hypotension during beach chair positioning'}, {'measure': 'Interscalene block and beach chair positioning', 'timeFrame': '2 years', 'description': 'Effect of interscalene block on bradycardia during beach chair positioning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder surgery', 'Beach chair position', 'Interscalene block', 'HRV', 'Autonomic nervous system'], 'conditions': ['Shoulder Surgery', 'Beach Chair Position', 'Interscalene Block', 'HRV', 'Autonomic Nervous System']}, 'referencesModule': {'references': [{'pmid': '3970172', 'type': 'BACKGROUND', 'citation': 'Pomeranz B, Macaulay RJ, Caudill MA, Kutz I, Adam D, Gordon D, Kilborn KM, Barger AC, Shannon DC, Cohen RJ, et al. Assessment of autonomic function in humans by heart rate spectral analysis. Am J Physiol. 1985 Jan;248(1 Pt 2):H151-3. doi: 10.1152/ajpheart.1985.248.1.H151.'}, {'pmid': '2874900', 'type': 'BACKGROUND', 'citation': "Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178."}, {'type': 'BACKGROUND', 'citation': 'Muzi M, Ebert Tj. Quantification of heart rate variability with power spectral analysis. Current Opinion in Aneasthesiology 6: 3-17, 1993'}, {'pmid': '1860193', 'type': 'BACKGROUND', 'citation': 'Malliani A, Pagani M, Lombardi F, Cerutti S. Cardiovascular neural regulation explored in the frequency domain. Circulation. 1991 Aug;84(2):482-92. doi: 10.1161/01.cir.84.2.482.'}, {'pmid': '13330193', 'type': 'BACKGROUND', 'citation': 'RANDALL WC, ROHSE WG. The augmentor action of the sympathetic cardiac nerves. Circ Res. 1956 Jul;4(4):470-5. doi: 10.1161/01.res.4.4.470. No abstract available.'}, {'pmid': '655444', 'type': 'BACKGROUND', 'citation': 'Rogers MC, Battit G, McPeek B, Todd D. Lateralization of sympathetic control of the human sinus node: ECG changes of stellate ganglion block. Anesthesiology. 1978 Feb;48(2):139-41. doi: 10.1097/00000542-197802000-00009. No abstract available.'}, {'pmid': '1860195', 'type': 'BACKGROUND', 'citation': 'Schwartz PJ, Locati EH, Moss AJ, Crampton RS, Trazzi R, Ruberti U. Left cardiac sympathetic denervation in the therapy of congenital long QT syndrome. A worldwide report. Circulation. 1991 Aug;84(2):503-11. doi: 10.1161/01.cir.84.2.503.'}]}, 'descriptionModule': {'briefSummary': "The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for elective shoulder surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* elective shoulder surgery\n* Age 20- 45 years old\n* ASA I - II\n\nExclusion Criteria:\n\n* Coagulopathy disorders\n* Infection at the puncture site for the interscalene block\n* Neurologic deficit in the arm that is going to be operated\n* Allergy to local anesthetics\n* BMI \\> 35\n* Psychiatric disorders\n* Patient's refusal\n* Problems with patient communication\n* Arrythmia\n* Ischaemic heart disease\n* Diabetes mellitus\n* Thyroid function disorders\n* Patients with conduction disorders on the ECG\n* Electrolyte disorders (K+, Na+, Ca++)\n* Patients on medication that affect the ECG"}, 'identificationModule': {'nctId': 'NCT01185457', 'briefTitle': 'Effect of Interscalene Block on Heart Rate Variability (HRV)', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': "Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement", 'orgStudyIdInfo': {'id': 'HRVShoulder'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Left interscalene block', 'description': 'Left shoulder surgery under left interscalene block and HRV'}, {'label': 'Right interscalene block', 'description': 'Right shoulder surgery under right interscalene block and HRV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'Larissa University Hospital', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Eleni Chantzi, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'George Vretzakis, Medicine', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Metaxia Bareka, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Christos Iatrou, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandroupoli University Hospital'}, {'name': 'Theophilos Karachalios, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Marina Simaioforidou, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Eleni Chantzi', 'investigatorAffiliation': 'Larissa University Hospital'}}}}