Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
Study NCT ID:
NCT06800859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-30
First Post:
2025-01-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of a Predictive Model for Post-dural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001510', 'term': 'Bed Rest'}, {'id': 'D017217', 'term': 'Blood Patch, Epidural'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter (ONSD) measurement by MRI', 'timeFrame': '1 hour before dural puncture', 'description': 'ONSD Measurement by MRI'}, {'measure': 'Optic nerve sheath diameter (ONSD) measurement by MRI', 'timeFrame': '24 hours after dural puncture', 'description': 'ONSD Measurement by MRI'}, {'measure': 'Optic nerve sheath diameter (ONSD) measurement by B ultrasound', 'timeFrame': '1 hour before dural puncture', 'description': 'ONSD Measurement by B ultrasound'}, {'measure': 'Optic nerve sheath diameter (ONSD) measurement by B ultrasound', 'timeFrame': '8 hours after dural puncture', 'description': 'ONSD Measurement by B ultrasound'}, {'measure': 'Optic nerve sheath diameter (ONSD) measurement by B ultrasound', 'timeFrame': '24 hours after dural puncture', 'description': 'ONSD Measurement by B ultrasound'}, {'measure': 'Optic nerve sheath diameter (ONSD) measurement by B ultrasound', 'timeFrame': '48 hours after dural Puncture', 'description': 'ONSD Measurement by B ultrasound'}, {'measure': 'Intraocular Pressure messurement', 'timeFrame': '1 Hour before dural Puncture', 'description': 'Intraocular Pressure measurement by Icare'}, {'measure': 'Intraocular Pressure messurement', 'timeFrame': '8 hours after dural puncture', 'description': 'Intraocular Pressure measurement by Icare'}, {'measure': 'Intraocular Pressure messurement', 'timeFrame': '24 hours after dural puncture', 'description': 'Intraocular Pressure measurement by Icare'}, {'measure': 'Intraocular Pressure messurement', 'timeFrame': '48 hours after dural puncture', 'description': 'Intraocular Pressure measurement by Icare'}], 'secondaryOutcomes': [{'measure': 'number of punctures', 'timeFrame': '24 hours after dural puncture', 'description': 'number of punctures'}, {'measure': 'type of puncture needle', 'timeFrame': '24 hours after dural puncture', 'description': 'type of puncture needle'}, {'measure': 'Onset time of postoperative headache and duration', 'timeFrame': '24 hours after dural puncture', 'description': 'Onset time of postoperative headache" and "duration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal anestheisa', 'Pural-Puncture', 'Headache', 'Complications'], 'conditions': ['Spinal and Epidural Anaesthesia-Induced Headache During Pregnancy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to establish a predictive model for post-dural puncture headache. The main questions it aims to answer are:\n\nChanges in intracranial pressure after spinal puncture (or lumbar puncture). When post-dural puncture headache occurs, the optic nerve sheath diameter (ONSD) change When the optic nerve sheath diameter (ONSD) and (or) Intraocular Pressure (IOP) reaches a certain threshold, does proactive treatment reduce the incidence of postoperative headaches? Researchers will measure the optic nerve sheath diameter (ONSD) using ultrasound and ( or ) magnetic resonance imaging (MRI) before and after spinal puncture.\n\nResearchers will measure the Intraocular Pressure (IOP) using ICARE before and after spinal puncture.\n\nParticipants will:\n\nUndergo ultrasound and (or) magnetic resonance imaging (MRI) examinations before and after spinal puncture Undergo ICARE examinations before and after spinal puncture', 'detailedDescription': "Post-dural Puncture Headache (PDPH) refers to a specific type of headache that occurs after patients receive intrathecal anesthesia or a lumbar puncture, resulting from the leakage of cerebrospinal fluid (CSF) due to the puncture of the dura mater and arachnoid mater. This type of headache typically occurs within 24 to 48 hours after the puncture and is characterized primarily by positional headaches, meaning that the headache worsens when the patient is standing or sitting and improves when lying down. The headache is often accompanied by symptoms such as neck stiffness, nausea, vomiting, tinnitus, and blurred vision.\n\nThe primary mechanism of PDPH is the leakage of cerebrospinal fluid from the puncture site after the dura and arachnoid are punctured, leading to a decrease in CSF pressure. The reduction in cerebrospinal fluid can cause several physiological changes:Decreased CSF Pressure: The reduction of CSF leads to a drop in intracranial pressure, which alters the mechanisms that support the brain, resulting in pain.Meningeal Tension: The decrease in CSF may cause tension on the meninges and nerve roots, leading to pain sensations.Vasodilation: The drop in intracranial pressure can trigger a reflexive dilation of cerebral blood vessels, further exacerbating the pain.The incidence of PDPH is associated with various factors, including the patient's age, sex, body type, type of surgery performed, and the type and size of the puncture needle used. Smaller needles (such as 25G or thinner) and non-cutting needles (such as Sprotte needles) can significantly reduce the incidence of PDPH, whereas larger and cutting needles (such as Quincke needles) are associated with a higher incidence. Younger patients and females are more prone to developing PDPH. Additionally, multiple punctures increase the risk of PDPH.\n\nTimely and effective treatment can significantly reduce the occurrence of PDPH; however, there is currently a lack of monitoring methods for PDPH. This study aims to establish a predictive model for the occurrence of PDPH by measuring postural cerebrospinal fluid pressure using ultrasound, which can enable early prediction and treatment of PDPH, thereby significantly improving patient comfort and recovery processes.\n\nThe goal of this clinical trial is to establish a predictive model for post-dural puncture headache,with the goal of implementing proactive interventions and treatments to reduce the incidence of PDPH and improve clinical management. Therefore, establishing an effective early warning model is crucial Participants will receive ultrasound, magnetic resonance imaging (MRI) and (or ) ICARE examinations before and after spinal puncture"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '34 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who need dural puncture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI ≤ 30 kg/m² Normal liver and kidney function before surgery Normal coagulation function before surgery Hemoglobin \\> 70 g/L Platelet count \\> 80 × 10⁹/L\n\nExclusion Criteria:\n\nPatients who experience major bleeding during or after surgery Patients with cerebrospinal fluid leakage or other serious malformations Patients with mental health disorders or cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT06800859', 'briefTitle': 'Establishment of a Predictive Model for Post-dural Puncture Headache', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Establishment of a Predictive Model for Post-dural Puncture Headache', 'orgStudyIdInfo': {'id': '101787'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Post-dural Puncture Headache Group in adult', 'description': 'Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture'}, {'label': 'Post-dural Puncture Headache Group in adult', 'description': 'Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture', 'interventionNames': ['Drug: Supplement fluids']}, {'label': 'No Post-dural Puncture Headache Group in children', 'description': 'Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture'}, {'label': 'Post-dural Puncture Headache Group in children', 'description': 'Perform MRI and (or) ultrasound and (or) intraocular pressure measurement before and 24 hours after the puncture', 'interventionNames': ['Drug: Supplement fluids']}], 'interventions': [{'name': 'Supplement fluids', 'type': 'DRUG', 'otherNames': ['Bed rest', 'Blood patch'], 'description': "To ensure optimal recovery and manage potential complications, patients are advised to supplement fluids by increasing their oral intake or receiving intravenous fluids as necessary. Bed rest is recommended to reduce physical strain and promote healing. Additionally, a blood patch procedure may be performed to alleviate symptoms such as headaches that can occur after certain medical procedures, particularly spinal taps. This involves injecting a small amount of the patient's own blood into the epidural space to seal any leaks of cerebrospinal fluid, thereby providing relief and aiding in recovery. Proper monitoring and follow-up care are essential to ensure the effectiveness of these interventions", 'armGroupLabels': ['Post-dural Puncture Headache Group in adult', 'Post-dural Puncture Headache Group in children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital of Tongji Medical College of Huazhong Universtiy of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Yilin Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huazhong Universty of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yilin Zhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yilin Zhao', 'investigatorAffiliation': 'Tongji Hospital'}}}}