Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 2:38 PM
Study NCT ID:
NCT04732234
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.\n\nGroup C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-12-25', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': 'baseline till 24 hours postoperative', 'description': 'Total 24 hours morphine consumption in milligrams'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': 'Visual analogue scale (VAS) at baseline till 24 hours postoperative', 'description': 'scale in which 0 is least pain and 10 is sever pain'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'The superior hypogastric plexus (SHP) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. The perception of central pelvic pain is thought mainly to involve transmission through this plexus. Therefore, blocking or of SHP has been used to treat pelvic pain.', 'detailedDescription': 'Ultrasound guided superior hypogastric plexus block there is 2 equal groups:\n\nGroup S (SHPB group 18 patients) ultrasound guided SHPB is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml Bupivacaine 0.5% before skin incision, Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. Patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand.\n\n• Dosing and administration; Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.\n\nGroup C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II,III.\n* Patients undergoing pelvic surgeries.\n\nExclusion Criteria:\n\n* Patients refusal,\n* Coagulopathy,\n* Infection.'}, 'identificationModule': {'nctId': 'NCT04732234', 'briefTitle': 'Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Pre-emptive Ultrasound Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study', 'orgStudyIdInfo': {'id': 'IORG0003381-AP2006-50103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '( Group A)', 'description': 'ultrasound guided superior hypogastric plexus block using 20 ml Bupivacaine 0.5% before skin incision.', 'interventionNames': ['Procedure: Superior Hypogastric Plexus Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': '(Group B)', 'description': 'ultrasound guided superior hypogastric plexus block using 20 ml normal saline 0.9% instead of bupivacaine.', 'interventionNames': ['Procedure: Superior Hypogastric Plexus Block']}], 'interventions': [{'name': 'Superior Hypogastric Plexus Block', 'type': 'PROCEDURE', 'description': 'Pre operative ultrasound guided superior hypogastric plexus block in pelvic surgeries using a curvilinear probe below umbalicus with needle in plane technique to reach the plexus in front of L5 vertebra', 'armGroupLabels': ['( Group A)', '(Group B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Nataional Cancer Instituite', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed abdel wadod, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia & pain management Dept, National Cancer Institute-Cairo - Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohammed Abdelfattah Abdelwadod', 'investigatorFullName': 'Mohammed Abdelfattah Abdelwadod', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}