Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-01 @ 4:18 AM
Study NCT ID:
NCT02125994
Status:
UNKNOWN
Last Update Posted:
2014-04-29
First Post:
2014-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2014-04-27', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure fluctuations', 'timeFrame': 'Completion of the surgery'}], 'secondaryOutcomes': [{'measure': 'Heart rate fluctuations', 'timeFrame': 'Completion of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Surgery', 'Interscalene Nerve Block', 'Ropivacaine']}, 'descriptionModule': {'briefSummary': 'It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.\n\nThe investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elective shoulder surgery\n* Age 18- 80 years old\n* ASA I - IV\n* Beach chair position\n\nExclusion Criteria:\n\n* Coagulopathy disorders\n* Infection at the puncture site for the interscalene block\n* Neurological deficit on the side to be operated\n* Allergy to local anesthetics\n* Psychiatric disorders\n* Patient's refusal\n* Problems with patient communication\n* Failure of the interscalene block"}, 'identificationModule': {'nctId': 'NCT02125994', 'briefTitle': 'Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position', 'orgStudyIdInfo': {'id': 'Shoulder 0.5 vs 0.375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine 0.5%', 'description': 'Ultrasound guided Intercalene nerve block with ropivacaine 0.5 %', 'interventionNames': ['Procedure: Interscalene nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine 0.375 %', 'description': 'Ultrasound guided Intercalene nerve block with ropivacaine 0.375 %', 'interventionNames': ['Procedure: Interscalene nerve block']}], 'interventions': [{'name': 'Interscalene nerve block', 'type': 'PROCEDURE', 'armGroupLabels': ['Ropivacaine 0.375 %', 'Ropivacaine 0.5%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Larissa', 'state': 'Larissa', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Marina Simaioforidou, Medicine', 'role': 'CONTACT', 'email': 'msimaiof@gmail.com', 'phone': '00306972202573'}], 'facility': 'Private Clinic of Larissa "Asklipeiio"', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'centralContacts': [{'name': 'Marina Simaioforidou, Medicine', 'role': 'CONTACT', 'email': 'msimaiof@otenet.gr', 'phone': '0000306972202573'}], 'overallOfficials': [{'name': 'Marina Simaioforidou, Medicine', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Private Clinic of Larissa "Asklipeiio"'}, {'name': 'Metaxia Bareka, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Larisa'}, {'name': 'George Basdekis, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Private Clinic of Larissa "Asklipeiio"'}, {'name': 'Konstantinos Bargiotas, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Sokrates Varitimidis, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Aristeidis Zibis, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Private Clinic of Larissa "Asklipeiio"'}, {'name': 'Konstantinos Alexiou, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Marina Simaioforidou', 'investigatorAffiliation': 'Larissa University Hospital'}}}}