Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-26 @ 8:09 AM
Study NCT ID:
NCT04306666
Status:
UNKNOWN
Last Update Posted:
2020-03-13
First Post:
2019-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of analgesia', 'timeFrame': '24 hours', 'description': 'time to first rescue analgesic request (opioid)'}], 'secondaryOutcomes': [{'measure': 'maximal pain score during the first 24 hours after surgery', 'timeFrame': '24 hours', 'description': 'Pain assessments during first 24 hours : maximal pain score during the first 24 hours after surgery'}, {'measure': 'total rescue analgesia amounts the first 24 hours after surgery', 'timeFrame': '24 hours', 'description': 'Pain assessments during first 24 hours : total rescue analgesia amounts the first 24 hours after surgery'}, {'measure': 'duration of sensory block', 'timeFrame': '24 hours', 'description': 'Pain assessments during first 24 hours : duration of sensory block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional anesthesia', 'Walant block'], 'conditions': ['Hand Surgery', 'Wrist Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.\n\nThe main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.\n\nThe secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.', 'detailedDescription': 'data will be collected on patient records and will be compared between groups of regional anesthesia.\n\nData will be :\n\n* time to first analgesic request\n* sensory block\n* rescue analgesia during the first 24 hours after surgery\n* maximal pain score during the first 24 hours after surgery\n* patient satisfaction of managing care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults patients scheduled for hand or wrist ambulatory surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adults patients scheduled for hand or wrist ambulatory surgery since 2016\n\nExclusion criteria:\n\n\\- NA'}, 'identificationModule': {'nctId': 'NCT04306666', 'acronym': 'WalantBAX', 'briefTitle': 'Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.', 'orgStudyIdInfo': {'id': 'RECHMPL19_0429'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Walant group', 'description': 'Walant group', 'interventionNames': ['Other: Regional anesthesia']}, {'label': 'Axillary Brachial Plexus Block', 'description': 'Axillary Brachial Plexus Block', 'interventionNames': ['Other: Regional anesthesia']}], 'interventions': [{'name': 'Regional anesthesia', 'type': 'OTHER', 'description': 'Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.', 'armGroupLabels': ['Axillary Brachial Plexus Block', 'Walant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier CHOQUET, MD', 'role': 'CONTACT', 'email': 'o-choquet@chu-montpellier.fr', 'phone': '467338256', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'olivier CHOQUET, PhD', 'role': 'CONTACT', 'email': 'o-choquet@chu-montpellier.fr', 'phone': '467338256', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'olivier CHOQUET, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}