Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT04782206
Status:
UNKNOWN
Last Update Posted:
2021-03-04
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072716', 'term': 'Cancer Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'from 30 min. after procedure to 2 months after it', 'description': 'Visual Analogue Scale post-procedure'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'during the block procedure and within the first 24 hours after the block', 'description': 'including transient paresthesia, rectal puncture, vascular penetration of one of the pelvic vessels, hematoma, infection, dural puncture, bowel/bladder dysfunction, pain on injection, hypotension from the sympathetic block or any other complication'}, {'measure': 'procedure time', 'timeFrame': 'during the block procedure', 'description': 'The time required to perform the block'}, {'measure': 'Total oral analgesic consumption', 'timeFrame': 'in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it', 'description': 'total MST consumption'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic cancer pain', 'superior hypogastric plexus block', 'pulsed radiofrequency'], 'conditions': ['Pain Cancer', 'Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis that adding pulsed radiofrequency neuromodulation at S3 nerve root to superior hypogastric plexus chemical neurolysis improves analgesia in patients with chronic pelvic cancer pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pelvic cancer patients\n* with pelvic pain not responding to oral analgesic medications\n* side effects of oral analgesic medications\n\nExclusion Criteria:\n\n* patients with metastatic cancer disease\n* patients with significantly impaired organ functions\n* patients with bleeding diathesis\n* patients with mental disabilities'}, 'identificationModule': {'nctId': 'NCT04782206', 'briefTitle': 'S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study', 'orgStudyIdInfo': {'id': '366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'superior hypogastric plexus block', 'interventionNames': ['Procedure: superior hypogastric plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block', 'interventionNames': ['Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block']}], 'interventions': [{'name': 'superior hypogastric plexus block', 'type': 'PROCEDURE', 'description': 'superior hypogastric plexus chemical neurolysis', 'armGroupLabels': ['group 1']}, {'name': 'pulsed radiofrequency at S3 root plus superior hypogastric plexus block', 'type': 'PROCEDURE', 'description': 'pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis', 'armGroupLabels': ['group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor of Anesthesia, ICU, and Pain management', 'investigatorFullName': 'Ahmad Mohammad Abd El-Rahman', 'investigatorAffiliation': 'Assiut University'}}}}