Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 10:39 PM
Study NCT ID:
NCT03855059
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007869', 'term': 'Leg Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'plich@arizona.edu', 'phone': '5206267221', 'title': 'Peter Lichtenthal, MD', 'organization': 'University of Arizona/Deptartment of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Followed acutely for seven days post operative and 6 months for any post op complications', 'eventGroups': [{'id': 'EG000', 'title': 'Intervenous Steroid', 'description': 'Steroid given intervenously at the time of Peripheral nerve block', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Perineural Steroid', 'description': 'Steroid given in syringe with the local anesthetic', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Analgesia Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervenous Steroid', 'description': 'Steroid given intervenously at the time of Peripheral nerve block'}, {'id': 'OG001', 'title': 'Perineural Steroid', 'description': 'Steroid given in syringe with the local anesthetic'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 - 48 hours', 'description': 'The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervenous Steroid', 'description': 'Steroid given intervenously at the time of Peripheral nerve block'}, {'id': 'FG001', 'title': 'Perineural Steroid', 'description': 'Steroid given in syringe with the local anesthetic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervenous Steroid', 'description': 'Steroid given intervenously at the time of Peripheral nerve block'}, {'id': 'BG001', 'title': 'Perineural Steroid', 'description': 'Steroid given in syringe with the local anesthetic'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Population age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.24', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '18'}, {'value': '11.28', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '12.26', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', '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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-16', 'size': 146405, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-07T18:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The research pharmacist will randomize and prepare the necessary syringes for injection to look similar and have the same amount of solution as so the PI and anyone else does not know what is being given.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2019-02-25', 'resultsFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-30', 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia Duration', 'timeFrame': '24 - 48 hours', 'description': 'The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Limb Injury']}, 'descriptionModule': {'briefSummary': 'IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.', 'detailedDescription': 'The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to receive either steroid given IV or with the nerve block, the subject is anesthetized and the subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local anesthetic plus placebo or steroid in the nerve block, the block will be placed under ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 - 0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects will be called by the study PI after 24 hours to determine the time of duration and again at 48 hours if needed. This is a randomized, double blind study, neither the subject or the anesthesiologist giving the injection will know what is being given. The medications will be prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by the research pharmacist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to have a lower limb Orthopedic surgical procedure.\n* Scheduled to have a nerve block placed for post operative analgesia.\n* American Society of Anesthesiologist (ASA) Class I - III.\n\nExclusion Criteria:\n\n* Not scheduled to have a nerve block placed for post operative analgesia.'}, 'identificationModule': {'nctId': 'NCT03855059', 'briefTitle': 'IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery', 'orgStudyIdInfo': {'id': '02182019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': 'Depending on the randomization, this group will receive a saline solution either in the IV catheter or the saline solution will be given perineural with the Mepivicaine nerve block solution.', 'interventionNames': ['Drug: Placebos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone Sodium Phosphate', 'description': 'Depending on the randomization, this group will receive dexamethasone 0.1 - 0.15 mg/kg, either in the IV catheter or the dexamethasone, 0.1 - 0.15 mg/kg will be given perineural with the Mepivicaine nerve block solution.', 'interventionNames': ['Drug: Dexamethasone Sodium Phosphate']}], 'interventions': [{'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Non-active'], 'description': 'This will be a saline solution of given IV or perineural.', 'armGroupLabels': ['Placebos']}, {'name': 'Dexamethasone Sodium Phosphate', 'type': 'DRUG', 'otherNames': ['Active treatment'], 'description': 'This will be the active drug solution given IV or perineural.', 'armGroupLabels': ['Dexamethasone Sodium Phosphate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Peter R Lichtenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Anesthesiology', 'investigatorFullName': 'Peter R. Lichtenthal, MD', 'investigatorAffiliation': 'University of Arizona'}}}}