Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT04114058
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Michael.Banffy@cskerlanjobe.org', 'phone': '(310) 665-7200', 'title': 'Dr. Michael Banffy', 'organization': 'Cedar Sinai -Kerlan Jobe'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'We did not meet target enrollment due to safety concerns.'}}, 'adverseEventsModule': {'timeFrame': 'The adverse events occurred through post op days 1-7 for each patient.', 'description': 'An adverse event is defined as a fall post op.', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration'}, {'id': 'OG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.8'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '3.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post op days 1-4 (Average VAS score of first 4 days of post op)', 'description': 'pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.', 'unitOfMeasure': 'cm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Narcotic Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration'}, {'id': 'OG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'total pill taken over the course of days 1-4 post op.', 'description': 'Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.', 'unitOfMeasure': 'number of pills', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of at Home Falls.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration'}, {'id': 'OG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post op days 1-7', 'description': 'number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.', 'unitOfMeasure': 'total number of falls', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration'}, {'id': 'FG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control\n\nliposomal bupivicaine: local field infiltration'}, {'id': 'BG001', 'title': 'Fascia Iliaca Blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control\n\nFascia iliaca blockade: fascia iliaca compartment blockade'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], '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': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', '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': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '40'}, {'value': '25.7', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '40'}, {'value': '26.05', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'description': 'BMI utilized for each hip scope .It is a demographic characteristic not a result of the research medication that was being tested . As such, this as not analyzed and standard deviation is not necessary.', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Traction time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '120'}, {'value': '36.8', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '120'}, {'value': '36.4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '120'}]}]}], 'paramType': 'MEAN', 'description': 'Traction time s utilized for each hip scope .It is a demographic characteristic not a result of the research medication that was being tested . As such, this as not analyzed and standard deviation is not necessary.', 'unitOfMeasure': 'MINUTES', 'dispersionType': 'FULL_RANGE'}, {'title': 'pre-op Visual analogue scale score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'description': 'Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. 0 equals no pain and 10 represents the worst pain.', 'unitOfMeasure': 'CM', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-27', 'size': 368173, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-14T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2019-09-04', 'resultsFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-19', 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'post op days 1-4 (Average VAS score of first 4 days of post op)', 'description': 'pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.'}], 'secondaryOutcomes': [{'measure': 'Narcotic Utilization', 'timeFrame': 'total pill taken over the course of days 1-4 post op.', 'description': 'Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.'}, {'measure': 'Total Number of at Home Falls.', 'timeFrame': 'Post op days 1-7', 'description': 'number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip arthroscopy'], 'conditions': ['Femoro Acetabular Impingement']}, 'referencesModule': {'references': [{'pmid': '28802777', 'type': 'BACKGROUND', 'citation': 'Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.'}, {'pmid': '24061718', 'type': 'BACKGROUND', 'citation': 'Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy', 'detailedDescription': 'The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (\\>18 years old)\n* diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.\n\nExclusion Criteria:\n\n* patients undergoing revision procedures, bilateral procedures,\n* advanced osteoarthritis (\\<2mm joint space on plain radiographs)\n* frank dysplasia (anterior and/or lateral center edge angles \\<20 degrees and/or Tonnis angle \\>15 degrees)\n* diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).\n* allergy to liposomal bupivicaine'}, 'identificationModule': {'nctId': 'NCT04114058', 'briefTitle': 'A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine', 'orgStudyIdInfo': {'id': 'Pro00056482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivicaine', 'description': 'Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control', 'interventionNames': ['Drug: liposomal bupivicaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fascia iliaca blockade', 'description': 'Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control', 'interventionNames': ['Procedure: Fascia iliaca blockade']}], 'interventions': [{'name': 'liposomal bupivicaine', 'type': 'DRUG', 'otherNames': ['exparel'], 'description': 'local field infiltration', 'armGroupLabels': ['Liposomal Bupivicaine']}, {'name': 'Fascia iliaca blockade', 'type': 'PROCEDURE', 'description': 'fascia iliaca compartment blockade', 'armGroupLabels': ['fascia iliaca blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kerlan Jobe', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael Banffy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Orthopaedic Sports Medicine Fellowship', 'investigatorFullName': 'Michael Banffy, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}