Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-27 @ 8:51 AM
Study NCT ID:
NCT06312904
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-26', 'size': 294106, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-03-08T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of postoperative mechanical ventilation', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'Length of ICU/hospital stay', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'The incidence of respiratory depression', 'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'The respiratory depression is defined as: with no obvious upper respiratory tract obstruction: SpO2 \\< 90% and lasts for more than one minute, or respiratory rate \\< 8 times/min, or SpO2 \\< 94% and respiratory rate \\< 10 times/min, or supplemental oxygen is needed to maintain SpO2 \\> 94%.'}, {'measure': 'The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively', 'timeFrame': 'through study completion, an average of 2 weeks'}], 'primaryOutcomes': [{'measure': 'opioid consumption during the first 24h after surgery', 'timeFrame': '24 hours postoperatively', 'description': 'the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight'}], 'secondaryOutcomes': [{'measure': 'FPS-R scale recorded at 6, 12, 18 and 24h postoperatively', 'timeFrame': '24 hours postoperatively', 'description': 'The Faces Pain Scale-Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The bedside nurse will show the patients a picture of six faces, and score 0, 2, 4, 6, 8, and 10 from left to right. "0" equals "no pain" and "10" equals "very much pain." They will ask the patient to choose a face that represents their current pain condition and record the pain score.'}, {'measure': 'The rate of opioid treatment for remedial analgesia between groups', 'timeFrame': '24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative analgesia', 'paravertebral block', 'pediatric cardiac surgery', 'enhanced recovery after surgery'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '39510785', 'type': 'DERIVED', 'citation': 'Guo J, Tian L, Kang W, Jia Y, Yuan S. Effects of paravertebral block on postoperative analgesia in children undergoing unilateral thoracotomy cardiac surgery with cardiopulmonary bypass: protocol for a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e086462. doi: 10.1136/bmjopen-2024-086462.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 6-14 years old;\n2. Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;\n3. Inform consent signed by the parent or legal guardian.\n\nExclusion Criteria:\n\n1. Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;\n2. Emergency surgery or redo cardiac surgery;\n3. Body weight more than 50kg;\n4. Diagnosed as severe pulmonary hypertension;\n5. Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;\n6. Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study;\n7. Preoperative platelet counts less than 100\\*109/L, coagulopathy or bleeding tendency ;\n8. Preoperatively using antiplatelets or anticoagulants;\n9. Diagnosed with scoliosis or other contraindications for PVB.'}, 'identificationModule': {'nctId': 'NCT06312904', 'briefTitle': 'Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-GSP-QN-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paravertebral block group', 'description': 'This group of patients will undergo postoperative paravertebral block.', 'interventionNames': ['Procedure: paravertebral block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'local infiltration group', 'description': 'This group of patients will undergo postoperative local infiltration anesthesia.', 'interventionNames': ['Procedure: Local infiltration anesthesia']}], 'interventions': [{'name': 'paravertebral block', 'type': 'PROCEDURE', 'description': 'After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.', 'armGroupLabels': ['paravertebral block group']}, {'name': 'Local infiltration anesthesia', 'type': 'PROCEDURE', 'description': 'After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.', 'armGroupLabels': ['local infiltration group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Fuwai Hospital, National Center for Cardiovascular Diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jingfei Guo', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Hospital, National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org.cn', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2025.1-2026.1', 'ipdSharing': 'YES', 'description': 'The original data will be published in 2025 on http://www.medresman.org.cn'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Department of Anesthesiology', 'investigatorFullName': 'Jingfei Guo', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}