Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT03893318
Status:
TERMINATED
Last Update Posted:
2025-11-12
First Post:
2019-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IV Lidocaine in Pediatric AIS
Sponsor:
Organization:
Raw JSON
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It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'will receive saline placebo during and after surgery.\n\nPlacebos: Saline'}], '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': 'Study Group', 'description': 'will receive intravenous lidocaine during and after posterior spinal fusion for AIS\n\nIV lidocaine: an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'will receive saline placebo during and after surgery.\n\nPlacebos: Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '14.4', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '13.9', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_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': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'BG000', 'lowerLimit': '18.5', 'upperLimit': '36'}, {'value': '23.4', 'groupId': 'BG001', 'lowerLimit': '19.9', 'upperLimit': '30.5'}, {'value': '23.1', 'groupId': 'BG002', 'lowerLimit': '18.5', 'upperLimit': '30.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-16', 'size': 457219, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-15T12:17', 'hasProtocol': True}, {'date': '2024-01-19', 'size': 224375, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-15T12:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study Drug'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'PI moved to a different institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2019-02-21', 'resultsFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-27', 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': 'up to 6 weeks after surgery', 'description': 'measured in morphine-equivalent dosage (MED)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery']}, 'descriptionModule': {'briefSummary': 'This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.', 'detailedDescription': 'a Phase IV, randomized, triple-blind, placebo-controlled trial with two study groups: postoperative standard of care with opioid patient controlled analgesia (PCA) and IV lidocaine infusion versus postoperative standard of care plus normal saline placebo. Block randomization into one of the two groups will be based on a random table generated using an R-program. Group 1 (Study) will receive intravenous lidocaine during and after posterior spinal fusion for AIS. Group 2 (Control) will receive saline placebo during and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion.\n2. Ages between 12 and 18 years of age.\n3. Parent/Guardian capable of providing informed consent for study participation\n\nExclusion Criteria:\n\n1. Age \\< 12 or \\> 18 years old.\n2. Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.\n3. Diagnosis of sepsis or infection\n4. Diagnosis of primary or metastatic malignancy.\n5. Participation in another clinical trial.\n6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.\n7. Past or current seizure disorders.\n8. Allergy to bupivacaine.\n9. Planned anterior approaches for treatment of scoliosis deformity.\n10. Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)\n11. Ward of the State children'}, 'identificationModule': {'nctId': 'NCT03893318', 'acronym': 'PEDS LIDO', 'briefTitle': 'IV Lidocaine in Pediatric AIS', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '201807071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'will receive intravenous lidocaine during and after posterior spinal fusion for AIS', 'interventionNames': ['Drug: IV lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'will receive saline placebo during and after surgery.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'IV lidocaine', 'type': 'DRUG', 'description': 'an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.', 'armGroupLabels': ['Study Group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Saline', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes Jewish Hospital and St. Louis Children Hospital / Washington University in St. Louis School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Scott Luhmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Louis Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}