Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT02374320
Status:
TERMINATED
Last Update Posted:
2024-05-21
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exparel as a Nerve Block for Severe Hand Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017675', 'term': 'CREST Syndrome'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D011928', 'term': 'Raynaud Disease'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D045745', 'term': 'Scleroderma, Limited'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, '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', 'description': '20 mL liposomal bupivacaine injected once\n\nliposomal bupivacaine: injected as an axillary block', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radial and Ulnar Arterial Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-block (Baseline)', 'description': '20 mL liposomal bupivacaine injected once\n\nliposomal bupivacaine: injected as an axillary block'}, {'id': 'OG001', 'title': 'One Hour Post Block'}], 'classes': [{'title': 'Ulnar artery diameter', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.234'}, {'value': '.20', 'groupId': 'OG001', 'lowerLimit': '0.107', 'upperLimit': '0.254'}]}]}, {'title': 'Radial artery diameter', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.234'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.336'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Measured by Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Mean Numerical Rating Scale Pain Score', 'description': '20 mL liposomal bupivacaine injected once\n\nliposomal bupivacaine: injected as an axillary block'}, {'id': 'OG001', 'title': 'Mean Numerical Rating Scale Pain Score at 30 Days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exparel (Bupivacaine Liposome Injectable Suspension)', 'description': '20 mL Exparel (bupivacaine liposome injectable suspension) injected once\n\nliposomal bupivacaine: injected as an axillary block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exparel', 'description': '20 mL liposomal bupivacaine injected once\n\nliposomal bupivacaine: injected as an axillary block'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], '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': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'PI leaving institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2015-02-23', 'resultsFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-24', 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial and Ulnar Arterial Diameter', 'timeFrame': '1 hour', 'description': 'Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.'}], 'secondaryOutcomes': [{'measure': 'Pain Measured by Numerical Rating Scale', 'timeFrame': '1 month', 'description': 'Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['CREST Syndrome', 'Peripheral Vascular Disease', 'Raynaud Disease', 'Scleroderma, Diffuse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) status I-IV\n\nExclusion Criteria:\n\n* True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine\n* Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)\n* Pregnancy\n* Severe hepatic impairment\n* Evidence of infection at or near the proposed needle insertion site\n* Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee'}, 'identificationModule': {'nctId': 'NCT02374320', 'briefTitle': 'Exparel as a Nerve Block for Severe Hand Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine', 'orgStudyIdInfo': {'id': '2014.155.C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel', 'description': '20 mL liposomal bupivacaine injected once', 'interventionNames': ['Drug: liposomal bupivacaine']}], 'interventions': [{'name': 'liposomal bupivacaine', 'type': 'DRUG', 'description': 'injected as an axillary block', 'armGroupLabels': ['Exparel']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Soberon, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jose Soberon, MD', 'investigatorAffiliation': 'Ochsner Health System'}}}}