Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02383134
Status:
UNKNOWN
Last Update Posted:
2015-05-13
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximal Distance for Successful Supraclavicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': '•The onset time of sensory and motor block', 'timeFrame': 'the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin'}, {'measure': 'The proportion of inadequate and failed blocks.', 'timeFrame': 'the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin'}, {'measure': 'The presence of other complications such as hematoma, infection, pneumothorax.', 'timeFrame': 'up to 48 hours post operative.'}]}, 'conditionsModule': {'conditions': ['Regional Anesthesia', 'Ultrasound', 'Supraclavicular Block']}, 'descriptionModule': {'briefSummary': 'The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.\n\nThe ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.\n\nThis study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing upper limb surgery surgery (hand, forearm, elbow)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-III\n* 18-85 years of age, inclusive\n* surgery less than 3 hours\n\nExclusion Criteria:\n\n* contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)\n* existing neurological deficit in the area to be blocked\n* pregnancy\n* history of neck surgery or radiotherapy\n* inability to understand the informed consent and demands of the study'}, 'identificationModule': {'nctId': 'NCT02383134', 'briefTitle': 'Maximal Distance for Successful Supraclavicular Block', 'organization': {'class': 'OTHER', 'fullName': 'Tunisian Military Hospital'}, 'officialTitle': 'The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'TunisianMH'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunisian Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor, MD', 'investigatorFullName': 'Dr trabelsi walid', 'investigatorAffiliation': 'Tunisian Military Hospital'}}}}