Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 1:40 PM
Study NCT ID:
NCT02501135
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block
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': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heather.dellinger@nationwidechildrens.org', 'phone': '6147222997', 'title': 'Clinical Research Coordinator', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.\n\nFemoral nerve block with ropivacaine or bupivacaine', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 0, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Local Anesthetic Injected for Femoral Nerve Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.\n\nFemoral nerve block with ropivacaine or bupivacaine'}], 'classes': [{'title': 'Patients who received ropivacaine 0.2%', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': 'Patients who received ropivacaine 0.5%', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Patients who received bupivacaine 0.25%', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total mg of Local Anesthetic Injected for Femoral Nerve Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.\n\nAmount of femoral nerve block with ropivacaine or bupivacaine'}], 'classes': [{'title': 'Amount of ropivacaine 0.2%', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.35'}]}]}, {'title': 'Amount of ropivacaine 0.5%', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.35'}]}]}, {'title': 'Amount of bupivacaine 0.25%', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'length of surgery', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraoperative Tylenol Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Tylenol Consumption', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block and their Tylenol consumptiong during surgery'}], 'classes': [{'title': 'Increased Tylenol use in ropivacaine 0.5% NB', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Increased Tylenol use in ropivacaine 0.2% NB', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Increased Tylenol use in bupivacaine 0.25% NB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'length of surgery', 'description': 'Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-operative Opioids Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Operative Opioid Consumption', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block and their opioid consumption in PACU'}], 'classes': [{'title': 'IV Morphine who got ropivacaine 0.5% nerve block', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.04'}]}]}, {'title': 'IV Morphine who got ropivacaine 0.2% nerve block', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.07'}]}]}, {'title': 'IV Morphine who got bupivacaine 0.25% nerve block', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'in PACU (1 hr post-op)', 'description': 'Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge From PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discharge From PACU in Minutes', 'description': 'The amount of time spent in the post-anesthesia care unit (PACU) in minutes'}], 'classes': [{'title': 'PACU time in pt who got ropivacaine 0.2%', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '76'}]}]}, {'title': 'PACU time in pt who got ropivacaine 0.5%', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '68'}]}]}, {'title': 'PACU time in pt who got bupivacaine 0.25%', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient was excluded from analysis of time to PACU discharge due to a missing PACU arrival time.'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Scale Using FLACC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLACC Pain Scores', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block and their FLACC pain scores'}], 'classes': [{'title': 'FLACC in patient who had ropivacaine 0.2%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'FLACC in patient who had ropivacaine 0.5%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'FLACC in patient who had bupivacaine 0.25%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour post-op', 'description': 'The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '63 of the 281 total subjects had their pain assessed using the FLACC pain scale.'}, {'type': 'SECONDARY', 'title': 'Post-operative Pain Scale Using VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VAS Pain Scores', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block and their VAS pain scores'}], 'classes': [{'title': 'Ropivacaine 0.2%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Ropivacaine 0.5%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Bupivacaine 0.25%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour post-op', 'description': 'The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '197 out of the total 281 subjects had their pain assessed using VAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.\n\nFemoral nerve block with ropivacaine or bupivacaine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.\n\nFemoral nerve block with ropivacaine or bupivacaine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '281', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-21', 'size': 305036, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-15T09:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-06', 'studyFirstSubmitDate': '2015-05-28', 'resultsFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-06', 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Local Anesthetic Injected for Femoral Nerve Block', 'timeFrame': 'length of surgery'}, {'measure': 'Total mg of Local Anesthetic Injected for Femoral Nerve Block', 'timeFrame': 'length of surgery'}, {'measure': 'Intraoperative Tylenol Administered', 'timeFrame': 'length of surgery', 'description': 'Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.'}, {'measure': 'Post-operative Opioids Administered', 'timeFrame': 'in PACU (1 hr post-op)', 'description': 'Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine'}], 'secondaryOutcomes': [{'measure': 'Time to Discharge From PACU', 'timeFrame': 'Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour'}, {'measure': 'Post-operative Pain Scale Using FLACC', 'timeFrame': '1 hour post-op', 'description': 'The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.'}, {'measure': 'Post-operative Pain Scale Using VAS', 'timeFrame': '1 hour post-op', 'description': 'The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral nerve blocks', 'children', 'knee and thigh surgery'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who have undergone anesthesia and received a femoral nerve block at Nationwide Children'ts Hospital from 2010-2015 utilizing our EMR - PICIS.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I or II\n* Age \\< or equal to 18 years of age at time of femoral nerve block\n* Femoral nerve block performed from 2010-2015\n\nExclusion Criteria:\n\n* ASA physical status \\> II\n* Co-morbid diseases (cardiac, pulmonary, neurological disease)\n* Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone'}, 'identificationModule': {'nctId': 'NCT02501135', 'briefTitle': 'A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'A Retrospective Investigation of Safety and Efficacy From Increasing Concentrations of Local Anesthetic in Pediatric Femoral Nerve Blocks', 'orgStudyIdInfo': {'id': 'IRB 15-00396'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Femoral Nerve Blocks', 'description': 'Patients who receive ropivacaine or bupivacaine during femoral nerve block.', 'interventionNames': ['Procedure: Femoral nerve block with ropivacaine or bupivacaine']}], 'interventions': [{'name': 'Femoral nerve block with ropivacaine or bupivacaine', 'type': 'PROCEDURE', 'armGroupLabels': ['Femoral Nerve Blocks']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giorgio Veneziano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giorgio Veneziano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Giorgio Veneziano', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}