Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 8:42 AM
Study NCT ID:
NCT00923494
Status:
WITHDRAWN
Last Update Posted:
2017-01-20
First Post:
2009-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Ultrasound (US) Guided Supraclavicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to enroll. Change in patient population.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of analgesia', 'timeFrame': 'First 30 minutes'}, {'measure': 'Duration of analgesia', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Total analgesic use', 'timeFrame': 'First 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anesthesia'], 'conditions': ['Analgesia', 'Pain']}, 'descriptionModule': {'briefSummary': 'This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18-64,\n* Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.\n\nExclusion Criteria:\n\n* Emergency surgery,\n* Patient or surgeon refusal\n* Patients for which peripheral nerve block or study medications are contraindicated,\n* Patients on chronic analgesic therapy at home,\n* History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).'}, 'identificationModule': {'nctId': 'NCT00923494', 'briefTitle': 'Effectiveness of Ultrasound (US) Guided Supraclavicular Block', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%', 'orgStudyIdInfo': {'id': 'H-24506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group R20', 'description': 'Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'interventionNames': ['Drug: 20 ml of ropivacaine 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group R30', 'description': 'Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'interventionNames': ['Drug: 30 ml of ropivacaine 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group R40', 'description': 'Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'interventionNames': ['Drug: 40 ml of ropivacaine 0.5%']}], 'interventions': [{'name': '20 ml of ropivacaine 0.5%', 'type': 'DRUG', 'description': 'Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'armGroupLabels': ['Group R20']}, {'name': '30 ml of ropivacaine 0.5%', 'type': 'DRUG', 'description': 'Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'armGroupLabels': ['Group R30']}, {'name': '40 ml of ropivacaine 0.5%', 'type': 'DRUG', 'description': 'Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.', 'armGroupLabels': ['Group R40']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ben Taub General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jaime Ortiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Jaime Ortiz', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}