Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT00827658
Status:
TERMINATED
Last Update Posted:
2018-05-14
First Post:
2009-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2009-01-21', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome is efficacy of sensory anesthesia and analgesia', 'timeFrame': '15-45 minutes'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome is patient perceived discomfort with block', 'timeFrame': '15-45 Minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anesthesia, local', 'ulnar nerve', 'hand', 'surgery, plastic', 'blinded', 'randomized', 'prospective', 'local anesthesia', 'volar wrist block', 'hypothenar palm block', 'hand surgery'], 'conditions': ['Hand Surgery']}, 'descriptionModule': {'briefSummary': 'Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.\n\nExclusion Criteria:\n\n* patients unable to give informed consent\n* patients with previous or ongoing ulnar nerve deficits or neuropathy\n* patients undergoing Guyon's canal decompression\n* patients who can not comprehend or cooperate with assessment testing\n* patients with abnormal two point discrimination (\\> 6 mm at the test location) prior to the nerve block"}, 'identificationModule': {'nctId': 'NCT00827658', 'briefTitle': 'Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm', 'orgStudyIdInfo': {'id': 'McMaster 08-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypothenar Palm block', 'description': 'Hypothenar Palmar block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention.', 'interventionNames': ['Procedure: Hypothenar Palm block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volar Wrist Block', 'description': 'Volar Wrist block group. Local anesthetic is placed at this location in this study group. The same local composition (Intervention) is used for both study groups. The trial is a comparison of location not the Intervention.', 'interventionNames': ['Procedure: Volar Wrist Block']}], 'interventions': [{'name': 'Volar Wrist Block', 'type': 'PROCEDURE', 'description': 'Injection medial to Flexor Carpi Ulnaris Tendon at volar proximal wrist crease\n\nLocal Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)', 'armGroupLabels': ['Volar Wrist Block']}, {'name': 'Hypothenar Palm block', 'type': 'PROCEDURE', 'description': 'Injection at Hook of the Hamate on Palmar surface\n\nLocal Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)', 'armGroupLabels': ['Hypothenar Palm block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Stuart Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}