Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03577860
Status:
UNKNOWN
Last Update Posted:
2018-07-05
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-24', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-24', 'lastUpdatePostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of pulmonary function', 'timeFrame': '4 hour', 'description': 'Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography.'}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': '24 hours', 'description': 'Opioid consumption (Tramal - mg) will be recorded during the first 24 hours.'}, {'measure': 'Post-Operative pain', 'timeFrame': '24 hours', 'description': 'The post operative pain will be evaluated using Visual Analog Score for pain during the first 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brachial Plexus Block', 'Pulmonary Ventilation']}, 'referencesModule': {'references': [{'pmid': '17717249', 'type': 'RESULT', 'citation': 'Sinha SK, Abrams JH, Weller RS. Ultrasound-guided interscalene needle placement produces successful anesthesia regardless of motor stimulation above or below 0.5 mA. Anesth Analg. 2007 Sep;105(3):848-52. doi: 10.1213/01.ane.0000271912.84440.01.'}, {'pmid': '18682410', 'type': 'RESULT', 'citation': 'Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.'}, {'pmid': '21821517', 'type': 'RESULT', 'citation': 'Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4.'}, {'pmid': '2006740', 'type': 'RESULT', 'citation': 'Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.'}, {'pmid': '1539813', 'type': 'RESULT', 'citation': 'Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.'}, {'pmid': '20975468', 'type': 'RESULT', 'citation': 'Renes SH, van Geffen GJ, Rettig HC, Gielen MJ, Scheffer GJ. Minimum effective volume of local anesthetic for shoulder analgesia by ultrasound-guided block at root C7 with assessment of pulmonary function. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):529-34. doi: 10.1097/AAP.0b013e3181fa1190.'}, {'pmid': '8398959', 'type': 'RESULT', 'citation': 'Urmey WF, Gloeggler PJ. Pulmonary function changes during interscalene brachial plexus block: effects of decreasing local anesthetic injection volume. Reg Anesth. 1993 Jul-Aug;18(4):244-9.'}, {'pmid': '11767428', 'type': 'RESULT', 'citation': "Gottardis M, Luger T, Florl C, Schon G, Penz T, Resch H, Benzer A. Spirometry, blood gas analysis and ultrasonography of the diaphragm after Winnie's interscalene brachial plexus block. Eur J Anaesthesiol. 1993 Sep;10(5):367-9."}, {'pmid': '20485957', 'type': 'RESULT', 'citation': 'Hortense A, Perez MV, Amaral JL, Oshiro AC, Rossetti HB. Interscalene brachial plexus block. Effects on pulmonary function. Rev Bras Anestesiol. 2010 Mar-Apr;60(2):130-7, 74-8. doi: 10.1016/s0034-7094(10)70017-9. English, Portuguese, Spanish.'}, {'pmid': '19920426', 'type': 'RESULT', 'citation': 'Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.'}]}, 'descriptionModule': {'briefSummary': 'Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* shoulder surgery\n* indication of interscalene brachial plexus block\n* American Society of Anesthesiology Physical Status Classification I or II\n\nExclusion criteria:\n\n* refuse to participate\n* previous lung or diaphragma surgeries'}, 'identificationModule': {'nctId': 'NCT03577860', 'briefTitle': 'Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery', 'orgStudyIdInfo': {'id': '48739315.4.0000.5505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine 4ml', 'description': 'The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots', 'interventionNames': ['Drug: Bupivacaine 4 mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine 15ml', 'description': 'The interscalene brachial plexus block is performed with 15ml at level of C5-6', 'interventionNames': ['Drug: Bupivacaine 15 mL']}], 'interventions': [{'name': 'Bupivacaine 4 mL', 'type': 'DRUG', 'description': 'The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000', 'armGroupLabels': ['Bupivacaine 4ml']}, {'name': 'Bupivacaine 15 mL', 'type': 'DRUG', 'description': 'The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000', 'armGroupLabels': ['Bupivacaine 15ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Leonardo HC Ferraro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04024002', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Leonardo HC Ferraro, MD', 'role': 'CONTACT', 'email': 'leohcferraro@yahoo.com.br', 'phone': '+5511999516103'}], 'facility': 'Federal University of Sao Paulo - Hospital Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Leonardo HC Ferraro, PhD', 'role': 'CONTACT', 'email': 'leohcferraro@yahoo.com.br', 'phone': '+5511999516103'}], 'overallOfficials': [{'name': 'Leonardo HC Ferraro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leonardo Henrique Cunha Ferraro', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}