Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06631118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pericapsular Nerve Block Versus Propofol During Hip Fractures Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in VAS scale', 'timeFrame': '30 min after giving propofol and the PENG block.', 'description': 'The primary outcome will be difference in median reduction in VAS-D .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difference in Reduction in Visual Analogue Score at 30 Minutes']}, 'descriptionModule': {'briefSummary': 'The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients in the age group ranging 40-70, both genders, belonging to physical status American Society of Anaesthesiologists (ASA) I and II\n\nExclusion Criteria:\n\n* Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness and who refused to take part'}, 'identificationModule': {'nctId': 'NCT06631118', 'briefTitle': 'Pericapsular Nerve Block Versus Propofol During Hip Fractures Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Pericapsular Nerve Group (PENG) Block Versus Low Dose Propofol to Achieve Painless Sitting Position Before Spinal Anesthesia in Patients With Hip Fractures', 'orgStudyIdInfo': {'id': 'FMASU R 130/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group (A ) : will receive ultrasound guided pericapsular nerve group block (PENG) followed by spinal anesthesia.', 'interventionNames': ['Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Group B will receive low dose intravenous Propofol \\[0.7mg/kg\\] over 30 seconds followed by spinal anesthesia and so far, this is the most common and standard technique to achieve sitting position during spinal anesthesia for patients with hip fractures.', 'interventionNames': ['Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B']}], 'interventions': [{'name': 'pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B', 'type': 'PROCEDURE', 'description': 'Patients in group A will receive ultrasound guided pericapsular nerve group block (PENG) while patients in group B will receive low dose intravenous Propofol0.7mg/kg\\] over 30 seconds followed by spinal anesthesia in both groups', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Mamdouh Mohamed', 'role': 'CONTACT', 'email': 'marwaemam600@gmail.com', 'phone': '01000205686', 'phoneExt': '002'}, {'name': 'Mohamed Mourad Ali', 'role': 'CONTACT', 'email': 'mohamed_mourad@med.asu.edu.eg', 'phone': '01006512101', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Marwa Emam', 'investigatorAffiliation': 'Ain Shams University'}}}}