Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT02365961
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2015-02-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hip Scope Fascia-iliaca (FI) Block Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@hawkinsfoundation.com', 'phone': '864 454 7458', 'title': 'Hawkins Foundation Research Coordinator', 'organization': 'Hawkins Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed throughout their study participation, from surgery through the 3 month follow up.', 'description': 'Both treatment are standard of care.', 'eventGroups': [{'id': 'EG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 1, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 1, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hospital readmission', 'notes': '2 patients were readmitted for postoperative pain control.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'OG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '3.38'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.77', 'upperLimit': '3.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'OG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'classes': [{'categories': [{'measurements': [{'value': '26.87', 'groupId': 'OG000', 'lowerLimit': '22.37', 'upperLimit': '31.38'}, {'value': '30.32', 'groupId': 'OG001', 'lowerLimit': '26.03', 'upperLimit': '34.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)', 'unitOfMeasure': 'morphine milligram equivalents', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time in PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'OG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'classes': [{'categories': [{'measurements': [{'value': '150.04', 'groupId': 'OG000', 'lowerLimit': '128.95', 'upperLimit': '171.20'}, {'value': '151.59', 'groupId': 'OG001', 'lowerLimit': '131.52', 'upperLimit': '171.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of PACU stay in minutes from end of surgery to discharge from PACA', 'description': 'Measured time subjects spent in the post anesthesia care unit.', 'unitOfMeasure': 'Minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Number of Episodes of Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'OG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of surgery to discharge from PACU', 'description': 'Occurrences of periods of nausea and vomiting', 'unitOfMeasure': 'Number of episodes', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'OG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Number of participants that were readmitted to the hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'FG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)\n\nropivicaine\n\nclonidine\n\nEpinephrine'}, {'id': 'BG001', 'title': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin\n\nNoropin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-29', 'size': 131973, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-31T11:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2015-02-04', 'resultsFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-20', 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time in PACU', 'timeFrame': 'Duration of PACU stay in minutes from end of surgery to discharge from PACA', 'description': 'Measured time subjects spent in the post anesthesia care unit.'}, {'measure': 'Total Number of Episodes of Nausea and Vomiting', 'timeFrame': 'From end of surgery to discharge from PACU', 'description': 'Occurrences of periods of nausea and vomiting'}, {'measure': 'Hospital Readmission', 'timeFrame': '3 months', 'description': 'Number of participants that were readmitted to the hospital'}], 'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '3 Months', 'description': 'Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': '3 Months', 'description': 'Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip Arthroscopy'], 'conditions': ['Hip Dysplasia', 'Femoroacetabular Impingement', 'Acetabular Labrum Tear']}, 'referencesModule': {'references': [{'pmid': '31999469', 'type': 'DERIVED', 'citation': 'Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for outpatient hip arthroscopy\n* American Society of Anesthesiologists (ASA) 1-3\n\nExclusion Criteria:\n\n* Prior surgery on ipsilateral hip\n* ASA 4-6\n* Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day\n* Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes\n* Allergy to amide local anesthetics\n* Contraindication to regional anesthesia\n* BMI \\> 40\n* Females who are pregnant or plan to get pregnant during the course of the study'}, 'identificationModule': {'nctId': 'NCT02365961', 'briefTitle': 'Hip Scope Fascia-iliaca (FI) Block Study', 'organization': {'class': 'OTHER', 'fullName': 'The Hawkins Foundation'}, 'officialTitle': 'Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block', 'orgStudyIdInfo': {'id': 'Pro00038232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FI Block', 'description': 'Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \\[per 60 mL\\] and epinephrine 1:400,000)', 'interventionNames': ['Drug: ropivicaine', 'Drug: clonidine', 'Drug: Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local Injection', 'description': 'Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin', 'interventionNames': ['Drug: Noropin']}], 'interventions': [{'name': 'ropivicaine', 'type': 'DRUG', 'armGroupLabels': ['FI Block']}, {'name': 'clonidine', 'type': 'DRUG', 'armGroupLabels': ['FI Block']}, {'name': 'Epinephrine', 'type': 'DRUG', 'armGroupLabels': ['FI Block']}, {'name': 'Noropin', 'type': 'DRUG', 'armGroupLabels': ['Local Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Steadman Hawkins Clinic of the Carolinas - Greenville Health System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Eugene Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greenville Anesthesiology - Greenville Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hawkins Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}