Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02058303
Status:
TERMINATED
Last Update Posted:
2024-05-21
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D005383', 'term': 'Finger Injuries'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ken.bode@ochsner.org', 'phone': '504.842.1936', 'title': 'Ken Bode', 'organization': 'Ochsner Health System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exparel Forearm Block', 'description': 'Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.\n\nExparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine Supraclavicular Block', 'description': 'Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.\n\nBupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Onset of Sensorimotor Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel Forearm Block', 'description': 'Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.\n\nExparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.'}, {'id': 'OG001', 'title': 'Bupivacaine Supraclavicular Block', 'description': 'Under ultrasound guidance, 20-30 milliliters (mL) 0.5% Bupivacaine will be used for the supraclavicular block.\n\nBupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine'}], 'classes': [{'title': 'Median nerve block after 30 minutes', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '.81', 'groupId': 'OG001'}]}]}, {'title': 'Ulnar nerve block after 30 minutes', 'categories': [{'measurements': [{'value': '.933', 'groupId': 'OG000'}, {'value': '.818', 'groupId': 'OG001'}]}]}, {'title': 'Radial nerve block after 30 minutes', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '.864', 'groupId': 'OG001'}]}]}, {'title': 'Musculocutaneous nerve block after 30 minutes', 'categories': [{'measurements': [{'value': '.933', 'groupId': 'OG000'}, {'value': '.79', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.', 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies are due to a subset of subjects not achieving full blockade at 30 minutes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exparel Forearm Block', 'description': 'Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.\n\nExparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.'}, {'id': 'FG001', 'title': 'Bupivacaine Supraclavicular Block', 'description': 'Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.\n\nBupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exparel Forearm Block', 'description': 'Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.\n\nExparel Forearm block: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.'}, {'id': 'BG001', 'title': 'Bupivacaine Supraclavicular Block', 'description': 'Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.\n\nBupivacaine supraclavicular block: 20-30mL 0.5% bupivacaine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '0', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '0', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'PI leaving instutition', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2014-02-06', 'resultsFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-15', 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of Sensorimotor Block', 'timeFrame': '30 minutes', 'description': 'A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hand surgery', 'wrist surgery', 'finger surgery', 'anesthesia', 'regional anesthesia', 'postoperative pain'], 'conditions': ['Hand Injuries', 'Wrist Injuries', 'Finger Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 18 years or older having hand, wrist, or finger surgery\n* ability to understand and provide informed consent\n* American Society of Anesthesiologists status I-III\n* presence of a responsible adult caregiver for 48-72 hours after surgery\n\nExclusion Criteria:\n\n* patient refusal or inability to provide informed consent\n* true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol\n* pregnancy\n* hepatic or renal failure\n* evidence of infection at or near the proposed needle insertion site\n* any sensorimotor deficit of the upper extremity\n* BMI greater than or equal to 35\n* uncontrolled or severe pulmonary disease\n* anticoagulant use (not aspirin or non-steroidal anti-inflammatories)\n* chronic pain patients'}, 'identificationModule': {'nctId': 'NCT02058303', 'briefTitle': 'Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery', 'orgStudyIdInfo': {'id': '04262013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel forearm block', 'description': 'Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.', 'interventionNames': ['Drug: Exparel Forearm block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine supraclavicular block', 'description': 'Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.', 'interventionNames': ['Drug: Bupivacaine supraclavicular block']}], 'interventions': [{'name': 'Exparel Forearm block', 'type': 'DRUG', 'otherNames': ['bupivacaine liposome injectable suspension'], 'description': '20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.', 'armGroupLabels': ['Exparel forearm block']}, {'name': 'Bupivacaine supraclavicular block', 'type': 'DRUG', 'description': '20-30mL 0.5% bupivacaine', 'armGroupLabels': ['Bupivacaine supraclavicular block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Jose Soberon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Soberon, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jose Soberon, MD', 'investigatorAffiliation': 'Ochsner Health System'}}}}