Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 6:56 PM
Study NCT ID:
NCT02679560
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], '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': 'iebrown@ucdavis.edu', 'phone': '(916)734-1279', 'title': 'Dr. Ian Brown', 'organization': 'UC Davis'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.'}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.", 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered\n\nLiposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered\n\nRopivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild edema', 'notes': 'Mild edema at the site of IV placement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mild muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hallucination', 'notes': 'one episode of nighttime hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'notes': 'pruritus of lower extremity opposite injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diaphoresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated systolic blood pressure', 'notes': 'present prior to study enrollment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'intermittent nausea post-op', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'moderate orthostatic hypotension', 'notes': 'Moderate orthostatic hypotension (treated with normal saline bolus)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered\n\nLiposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine'}, {'id': 'OG001', 'title': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered\n\nRopivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.'}], 'timeFrame': 'Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.', 'description': 'Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents', 'reportingStatus': 'POSTED', 'populationDescription': 'There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.'}, {'type': 'SECONDARY', 'title': 'Patient Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered\n\nLiposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine'}, {'id': 'OG001', 'title': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered\n\nRopivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.'}], 'timeFrame': 'Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.', 'description': 'Total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay', 'reportingStatus': 'POSTED', 'populationDescription': 'There was a lack of enrollment and the sample size was too small to draw any results or conclusions for the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered\n\nLiposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine'}, {'id': 'FG001', 'title': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered\n\nRopivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered\n\nLiposomal Bupivacaine: A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine'}, {'id': 'BG001', 'title': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered\n\nRopivacaine HCL: Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '0', 'groupId': 'BG000'}, {'value': '33', 'spread': '14', 'groupId': 'BG001'}, {'value': '45', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-04', 'size': 570608, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-09T17:02', 'hasProtocol': True}, {'date': '2019-06-24', 'size': 357215, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-12-09T17:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2016-02-08', 'resultsFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2016-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-03', 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Requirements', 'timeFrame': 'Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.', 'description': 'Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Patient Outcomes', 'timeFrame': 'Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.', 'description': 'Total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['femur fracture, hip fracture, exparel, liposomal bupivacaine'], 'conditions': ['Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.', 'detailedDescription': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.\n\nThe long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age ≥18 years ≤ 70 years\n2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital\n3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.\n\nExclusion Criteria:\n\n1. \\>10 hours since presentation to the emergency department\n2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.\n3. Central or peripheral neurologic deficit on presentation\n4. Concern or compartment syndrome\n5. Associated additional long bone fractures\n6. End stage liver failure\n7. Renal failure requiring dialysis\n8. Pregnancy or breast feeding\n9. Prisoners\n10. Coagulopathy with INR \\>1.5\n11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)\n12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally\n13. Adults unable to consent\n14. Pediatric patients \\<18 years old\n15. Patients exhibiting signs of shock upon admission, HR \\>120 or SBP \\<100 mmHg.\n16. History of allergic reaction to local anesthetics\n17. Administration of any other local anesthetic in the 2 hours prior to the study enrollment.\n18. Distal femur fractures"}, 'identificationModule': {'nctId': 'NCT02679560', 'briefTitle': 'Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial', 'orgStudyIdInfo': {'id': '782382'}, 'secondaryIdInfos': [{'id': 'D6.715L15J91110', 'type': 'OTHER_GRANT', 'domain': 'Defense Health Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine', 'description': 'In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered', 'interventionNames': ['Drug: Liposomal Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ropivacaine HCL', 'description': 'In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered', 'interventionNames': ['Drug: Ropivacaine HCL']}], 'interventions': [{'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'otherNames': ['Exparel®'], 'description': 'A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine', 'armGroupLabels': ['Liposomal Bupivacaine']}, {'name': 'Ropivacaine HCL', 'type': 'DRUG', 'otherNames': ['Naropin (trade name)'], 'description': 'Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.', 'armGroupLabels': ['Ropivacaine HCL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Med Center- Trauma and Acute Care Surgery', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Ian Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ian Elliott Brown', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Ian Elliott Brown', 'investigatorAffiliation': 'University of California, Davis'}}}}