Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-30 @ 8:37 AM
Study NCT ID:
NCT05977361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}, {'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}], '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'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 181}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PDPH incidence', 'timeFrame': 'At 24 hours from UDP', 'description': 'Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence'}], 'secondaryOutcomes': [{'measure': 'PDPH intensity at 24 hours', 'timeFrame': 'At 24 hours from UDP', 'description': 'PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")'}, {'measure': 'PDPH intensity at 48 hours', 'timeFrame': 'At 48 hours from UDP', 'description': 'PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")'}, {'measure': 'Quality of analgesia', 'timeFrame': 'During the entire course of labour, an average of 12 hours', 'description': 'Quality of analgesia during labour will be evaluated, based on the number of additional boluses of local anesthetic administered during labour to treat breakthrough pain.'}, {'measure': 'Adverse events', 'timeFrame': 'During the entire follow-up period, up to 3 months from UDP', 'description': 'All reported adverse events, including number of unsuccessful attempts at placing the epidural or subarachnoid catheter, motor block, poor analgesia, caesarean section rate.'}, {'measure': 'Chronic pain at 1 month', 'timeFrame': 'At 1 month from UDP', 'description': 'Incidence of chronic headache and chronic low back pain'}, {'measure': 'Chronic pain at 3 months', 'timeFrame': 'At 3 months from UDP', 'description': 'Incidence of chronic headache and chronic low back pain'}, {'measure': 'Readmission to hospital', 'timeFrame': 'Up to 3 months from UDP', 'description': 'ER visits or hospital readmissions due to neurological symptoms related or possibly related to PDPH (severe headache, severe back pain, fever, leg weakness, incontinence of urine or stool)'}, {'measure': "Patient's satisfaction", 'timeFrame': 'Before discharge, an average of 1 week', 'description': "Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labor Pain', 'Obstetric Labor Complications', 'Analgesia, Epidural'], 'conditions': ['Analgesia, Obstetrical', 'Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'Epidural anesthesia represents the most popular method for pain relief during labour. Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia, representing therefore the most common complication. Up to 80% of patients with a UDP may develop a post-dural puncture headache (PDPH).\n\nWhen a UDP occurs, two possible strategies have been proposed in order to ensure analgesia during labour: either resiting the epidural catheter in a different intervertebral space, or inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during labour, but their relative contribution in preventing PDPH is still not known.\n\nThe primary aim of this multicenter randomized controlled trial is therefore to compare these two strategies in the occurrence of PDPH at 24 hours from the UDP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of UDP during labour\n* Written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* History of PDPH'}, 'identificationModule': {'nctId': 'NCT05977361', 'acronym': 'ItaREVI', 'briefTitle': 'Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ItaREVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resiting Epidural Catheter', 'interventionNames': ['Procedure: Resiting Epidural Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal catheter placement', 'interventionNames': ['Procedure: Intrathecal Catheter Placement']}], 'interventions': [{'name': 'Resiting Epidural Catheter', 'type': 'PROCEDURE', 'description': 'After a UDP has occurred, epidural catheter will be re-sited in a different intervertebral space. Analgesia will be then maintained according to internal protocol, using PIEB (Programmed Intermittent Epidural Bolus) system. Catheter will be left in place for the first 24-36 hours.', 'armGroupLabels': ['Resiting Epidural Catheter']}, {'name': 'Intrathecal Catheter Placement', 'type': 'PROCEDURE', 'description': 'After a UDP has occurred, an intrathecal catheter will be placed through the dural tap. Analgesia will be then maintained according to internal protocol, using PISB (Programmed Intermittent Subarachnoid Bolus) system. Catheter will be left in place for the first 24-36 hours. During this time, a continuous infusion of sterile saline at a rate of 2 mL/h will be maintained. Before removal, an additional bolus of 10 mL of sterile saline will be administered in the intrathecal catheter.', 'armGroupLabels': ['Intrathecal catheter placement']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bruno A Zanfini, MD, PhD', 'role': 'CONTACT', 'email': 'brunoantonio.zanfini@policlinicogemelli.it', 'phone': '06 3015 3105'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}