Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT02271867
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal QST for Interscale Block Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of sensory block', 'timeFrame': '24 hours after intervention'}], 'secondaryOutcomes': [{'measure': 'Degree of sensory stimulus detection threshold variation from baseline values', 'timeFrame': '24 hours after intervention', 'description': 'The higher the difference in detection threshold variation, the more intense the block. Measured as % change, where 100% change means no sensation on maximal QST stimulus (0°C for cold sensation and 50°C for warm sensation)'}, {'measure': 'Block duration', 'timeFrame': '24 hours after intervention'}, {'measure': 'Use of rescue medication', 'timeFrame': '24 hours after intervention'}, {'measure': 'Presence of motor block', 'timeFrame': '24 hours after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthetics, Local', 'Nerve Block']}, 'referencesModule': {'references': [{'pmid': '26475166', 'type': 'DERIVED', 'citation': 'Sermeus LA, Hans GH, Schepens T, Bosserez NM, Breebaart MB, Smitz CJ, Vercauteren MP. Thermal quantitative sensory testing to assess the sensory effects of three local anesthetic solutions in a randomized trial of interscalene blockade for shoulder surgery. Can J Anaesth. 2016 Jan;63(1):46-55. doi: 10.1007/s12630-015-0505-x. Epub 2015 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible\n\nExclusion Criteria:\n\n* contraindications for ISB\n* diabetes mellitus\n* peripheral neuropathy\n* patients receiving chronic analgesic therapy\n* contraindications for NSAID\n* patients with an initial QST with abnormal values'}, 'identificationModule': {'nctId': 'NCT02271867', 'briefTitle': 'Thermal QST for Interscale Block Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block', 'orgStudyIdInfo': {'id': 'EC 9/25/113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine 0,5%', 'description': 'Levobupivacaine 0,5% 15 ml once', 'interventionNames': ['Procedure: Interscalene block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine 0,5% with epinephrine', 'description': 'Levobupivacaine 0,5% with 1/200000 epinephrine 15 ml once', 'interventionNames': ['Procedure: Interscalene block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine 0,75%', 'description': 'Ropivacaine 0,75% 15 ml once', 'interventionNames': ['Procedure: Interscalene block']}], 'interventions': [{'name': 'Interscalene block', 'type': 'PROCEDURE', 'description': 'An ultrasound guided ISB was performed with injection aimed to block the C5-root', 'armGroupLabels': ['Levobupivacaine 0,5%', 'Levobupivacaine 0,5% with epinephrine', 'Ropivacaine 0,75%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thermal Quantitative Sensory Testing as a method to semi-quantitatively assess the neurosensory effects of 3 local anesthetic solutions in an interscalene block', 'investigatorFullName': 'Ethisch Comité UZ Antwerpen', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}