Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 11:33 PM
Study NCT ID:
NCT07149168
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-23', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of achieving adequate spinal anesthesia.', 'timeFrame': 'from injection to 24 hr post operative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain During Spinal Positioning']}, 'descriptionModule': {'briefSummary': 'the investigators will compare the effectiveness and safety of the pericapsular nerve block (PENG) using dexmedetomidine and bupivacaine before giving spinal anesthesia in improving the quality and success rate of spinal anesthesia for Fracture Neck Femur surgery versus spinal anesthesia alone.', 'detailedDescription': "\\- Pre-operative settings: Patients scheduled for Fracture Neck Femur surgery under spinal anesthesia will be thoroughly evaluated pre-operatively. A detailed medical history will be obtained, and all patients will undergo a comprehensive physical examination, with particular attention to neurological assessment to exclude any pre-existing conditions that might influence the study outcomes. Additionally, pre-operative laboratory tests, including complete blood count, and coagulation profile, will be reviewed to ensure patient eligibility and safety.\n\n2- Intraoperative Settings: Monitoring: Upon entering the operating room, standard monitoring will be applied to all patients, including pulse oximetry (SpO2), non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG). Baseline measurements will be recorded before any anesthetic intervention.\n\nIntravenous Access: An intravenous (IV) cannula will be inserted, and IV fluids will be initiated.\n\nGroup A (Control Group):\n\nFor spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12.\n\nGroup B (PENG Block Group):\n\nPatients in this group will first receive a pericapsular nerve block (PENG) before spinal anesthesia.\n\nThe PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg. This combination provides prolonged analgesia, enhances block effectiveness, and minimizes motor blockade, ensuring optimal pain control for fracture neck femur surgery.\n\nFollowing the successful administration of the PENG block, spinal anesthesia will be administered as described for Group A."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 18 years, scheduled for elective fracture neck femur surgery, • Physical status: ASAI-III.\n\nExclusion Criteria:\n\n* • Patients with contraindications to spinal anesthesia or regional blocks as:\n\n * significant coagulopathy\n * Known allergies to drugs used (Bupivacaine or dexmedetomidine)\n * Infection at site of injection\n\n * ASA IV\n * Cardiac patients with significant valve stenosis or sever pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT07149168', 'briefTitle': 'Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'FMASU MS 760/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': "patients will recieve For spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12", 'interventionNames': ['Drug: Bupivacain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Patients in this group will first receive a pericapsular nerve block (PENG) before spinal anesthesia.\n\nThe PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg. This combination provides prolonged analgesia, enhances block effectiveness, and minimizes motor blockade, ensuring optimal pain control for fracture neck femur surgery.\n\nFollowing the successful administration of the PENG block, spinal anesthesia will be administered as described for Group A.', 'interventionNames': ['Drug: Dexmedetomidin']}], 'interventions': [{'name': 'Dexmedetomidin', 'type': 'DRUG', 'description': 'The PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg', 'armGroupLabels': ['group B']}, {'name': 'Bupivacain', 'type': 'DRUG', 'description': "a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses", 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina Sameer Ahmed AboRaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'before 1/2026', 'ipdSharing': 'YES', 'description': 'all data will be shared once study is completed', 'accessCriteria': 'free'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}