Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-11 @ 6:18 PM
Study NCT ID:
NCT00653133
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2008-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Continuous Peripheral Nerve Block Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alan.dine@kcc.com', 'phone': '513-253-8033', 'title': 'Alan Dine Director of Clinical Research', 'organization': 'I-Flow Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'USPNB', 'description': 'ultrasound imaging guided peripheral nerve block', 'otherNumAtRisk': 1324, 'otherNumAffected': 7, 'seriousNumAtRisk': 1324, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NSPNB', 'description': 'Stimulator guided nerve block', 'otherNumAtRisk': 497, 'otherNumAffected': 14, 'seriousNumAtRisk': 497, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'VASCULAR PUNCTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 497, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'CATHETER SITE LOCAL INFECTION/INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 497, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'motor block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 497, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complications of Peripheral Nerve Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1324', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USPNB', 'description': 'Ultrasound imaging guided peripheral nerve block'}, {'id': 'OG001', 'title': 'NSPNB', 'description': 'Nerve Stimulator guided peripheral nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Preoperative through 3 days post operative', 'description': 'Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'USPNB', 'description': 'ultrasound imaging guided peripheral nerve block'}, {'id': 'FG001', 'title': 'NSPNB', 'description': 'Stimulator guided nerve block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1324'}, {'groupId': 'FG001', 'numSubjects': '497'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1324'}, {'groupId': 'FG001', 'numSubjects': '497'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1324', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '1821', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'USPNB', 'description': 'ultrasound imaging guided peripheral nerve block'}, {'id': 'BG001', 'title': 'NSPNB', 'description': 'Stimulator guided nerve block'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '843', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '1149', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '469', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '660', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '649', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '863', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '675', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '958', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1324', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '1821', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1821}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-01', 'studyFirstSubmitDate': '2008-03-28', 'resultsFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-16', 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications of Peripheral Nerve Block', 'timeFrame': 'Preoperative through 3 days post operative', 'description': 'Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'peripheral nerve block', 'peripheral nerve stimulation'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.', 'detailedDescription': 'Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.\n\nThis surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain\n* Age \\>18\n* Able to give consent\n\nExclusion Criteria:\n\n* Morbid obesity (BMI\\> 40)\n* Uncooperative or having psychological or linguistic difficulties\n* Previous damage to the nerve or plexus\n* Significant comorbidities which the primary investigator feels would limit the quality and collection of data\n* Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine'}, 'identificationModule': {'nctId': 'NCT00653133', 'acronym': 'cpnb', 'briefTitle': 'Multicenter Continuous Peripheral Nerve Block Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halyard Health'}, 'officialTitle': 'Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques', 'orgStudyIdInfo': {'id': 'iflocpnb2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'USPNB', 'description': 'Ultrasound imaging guided peripheral nerve block', 'interventionNames': ['Device: Ultrasound imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSPNB', 'description': 'Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic', 'interventionNames': ['Device: Peripheral nerve stimulator']}], 'interventions': [{'name': 'Ultrasound imaging', 'type': 'DEVICE', 'description': 'Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic', 'armGroupLabels': ['USPNB']}, {'name': 'Peripheral nerve stimulator', 'type': 'DEVICE', 'description': 'either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic', 'armGroupLabels': ['NSPNB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Joint and Spine', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '4088855230', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Avista Adventist Hospital', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}, {'zip': '30060', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kennestone Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Medical Center of Bowling Green', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '02072', 'city': 'Stoughton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Caritas Good Samaritan', 'geoPoint': {'lat': 42.1251, 'lon': -71.10227}}, {'zip': '39402', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Wesley Medical Center', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'DesPeres Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St. Vincents Catholic Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45459', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miami Valley Hospital', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '74055', 'city': 'Owasso', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Bailey Medical Center', 'geoPoint': {'lat': 36.26954, 'lon': -95.85471}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Roper Hospital', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Herman Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75455', 'city': 'Mount Pleasant', 'state': 'Texas', 'country': 'United States', 'facility': 'Titus Regional Medical Center', 'geoPoint': {'lat': 33.15679, 'lon': -94.96827}}, {'zip': '25298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Joe Rodrigo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roper Hospital, Charleston, SC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halyard Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}