Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 6:25 PM
Study NCT ID:
NCT03746951
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
Sponsor:
Organization:
Raw JSON
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It is performed by inserting the needle into the back.\n\nRopivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fascia Iliaca Compartment Block (FICB)', 'description': 'FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. 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{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '16'}, {'value': '13', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '16'}, {'value': '13', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', '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': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'BG000', 'lowerLimit': '25.3', 'upperLimit': '90.7'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '67.5'}, {'value': '59.7', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '167.5', 'groupId': 'BG000', 'lowerLimit': '118', 'upperLimit': '179.7'}, {'value': '150.4', 'groupId': 'BG001', 'lowerLimit': '119.8', 'upperLimit': '166.4'}, {'value': '158', 'groupId': 'BG002', 'lowerLimit': '122.7', 'upperLimit': '177.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-06', 'size': 348590, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-08T10:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2018-11-16', 'resultsFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Time to Perform the Regional Anesthesia Technique', 'timeFrame': 'Baseline', 'description': 'The amount of time if takes to perform either the FICB or LPB.'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption in the PACU', 'timeFrame': 'Immediately to 1 hour post-op', 'description': 'Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).'}, {'measure': 'Post-op Pain Scores', 'timeFrame': '48 hours post-op', 'description': 'Pain scores during the post-operative recovery period. Pain score scale is 0-10 with 0 being no pain and 10 being worst pain imaginable.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing orthopedic procedures involving the hip or upper femur. This study will help determine the efficacy of the two techniques and their advantages when compared to each other including time to perform the block, opioid consumption reduction, effects on postoperative pain, and the length of stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA grade I-III\n* Undergoing elective orthopedic surgical procedures involving the hip and upper thigh\n\nExclusion Criteria:\n\n* Local anesthetic allergy\n* Skin or localized infection at the site of catheter insertion\n* Patient or parent refusal'}, 'identificationModule': {'nctId': 'NCT03746951', 'briefTitle': 'Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks for Pain Management After Orthopedic Surgical Procedures Involving Hip and Femur in Pediatrics.', 'orgStudyIdInfo': {'id': 'IRB18-01102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fascia iliaca compartment block (FICB)', 'description': 'FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.', 'interventionNames': ['Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar plexus block (LPB)', 'description': 'LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.', 'interventionNames': ['Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml']}], 'interventions': [{'name': 'Ropivacaine Hcl 0.5% Inj Vil 20Ml', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'Anesthetic agent used in peripheral nerve block', 'armGroupLabels': ['Fascia iliaca compartment block (FICB)', 'Lumbar plexus block (LPB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthesiologist', 'investigatorFullName': 'Senthil G. Krishna', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}