Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06710405
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC (ace, Legs, Activity, Cry, Consolability scale) Score', 'timeFrame': 'up to 1 hour after surgery', 'description': 'Highest FLACC Score recorded in the postanesthesia care unit (The scale is scored in a range of 0-10 with 0 representing no pain.)'}], 'secondaryOutcomes': [{'measure': 'Remifentanil dose', 'timeFrame': 'throughout surgery (up to 3 hours)', 'description': 'Total amount of remifentanil administered during surgery'}, {'measure': 'ANI (Analgesia Nociception Index)', 'timeFrame': 'throughout surgery (up to 3 hours)', 'description': 'ANI (Analgesia Nociception Index) values during surgery (scale ranging from 0 (indicating maximum pain) to 100 (indicating no pain))'}, {'measure': 'FLACC scores', 'timeFrame': '6 hours, 12 hours, and 24 hours postoperatively', 'description': 'FLACC scores at 6 hours, 12 hours, and 24 hours postoperatively'}, {'measure': 'Total analgesic dosage administered postoperatively', 'timeFrame': 'up to 3 days after surgery'}, {'measure': 'Postoperative complications', 'timeFrame': 'until discharge (up to 3-4 days after surgery)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'thoracoscopic surgery', 'pain control', 'lidocaine'], 'conditions': ['Pain Management After Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection\n\nExclusion Criteria:\n\n* cardiac dysfunction requiring vasopressors or inotropic agents\n* atrioventricular block or bradycardia\n* Liver or kidney dysfunction\n* Hypersensitivity to local anesthetics'}, 'identificationModule': {'nctId': 'NCT06710405', 'briefTitle': 'The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H2409-100-1573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Anesthesia induction is performed according to the standard protocol. Monitoring includes electrocardiography, pulse oximetry, arterial blood pressure, depth of anesthesia (Patient State Index, PSI), and pain score (Analgesia Nociception Index).\n\nIn the lidocaine group, a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr.', 'interventionNames': ['Drug: Lidocaine (drug)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group.', 'interventionNames': ['Drug: Saline infusion (placebo)']}], 'interventions': [{'name': 'Lidocaine (drug)', 'type': 'DRUG', 'description': 'a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr.', 'armGroupLabels': ['Lidocaine group']}, {'name': 'Saline infusion (placebo)', 'type': 'DRUG', 'description': 'Continuous infusion of normal saline in the same volume as that administered to the lidocaine group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji-Hyun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'muslab6@snu.ac.kr', 'phone': '+82-10-7665-8848'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ji-Hyun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'muslab6@snu.ac.kr', 'phone': '82-2-2072-3661'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ji-Hyun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}