Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 8:32 PM
Study NCT ID:
NCT06990958
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Erector Spinae and Fascia Iliaca Blocks for Pain Relief After Femur Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-05-18', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of the block', 'timeFrame': '15 minutes after extubation till 24 hours postoperative', 'description': 'time starting immediatelyafter giving the block till the first postoperative analgesic rescue which will be used if the pain score exceeds 4/10'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fascia iliac block, erector spinae block, femur fracture, adult analgesia'], 'conditions': ['Analgesia After Fracture Femur Surgeries']}, 'descriptionModule': {'briefSummary': 'This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Both techniques are commonly used in hospitals to reduce postoperative pain.\n\nThe goal is to determine which nerve block provides more effective pain relief, reduces the need for opioid medications, and supports faster recovery in patients following femur surgery. Results from this study may improve pain management strategies for similar procedures in the future.\n\nAdults scheduled for proximal or midshaft femur surgery may be eligible to participate. Eligibility is determined based on clinical criteria reviewed by the study team.Administration of one of the two nerve blocks before surgery.Standard surgical and postoperative care.\n\nMonitoring of pain levels at specific time points after surgery\n\nRecording of opioid medication usage\n\nEvaluation of patient satisfaction and any side effects related to the nerve block\n\nDuration:\n\nThe intervention (nerve block) is administered once before surgery. Data collection continues during the immediate postoperative period and for a short time following surgery to assess outcomes.\n\nBoth nerve blocks are considered safe and are regularly used in clinical practice.\n\nAll procedures are performed by qualified clinicians, and safety monitoring is conducted throughout the study.\n\nParticipants may experience improved pain relief and reduced need for opioid medications. While direct benefit cannot be guaranteed, information gained from the study may help improve pain management for future patients undergoing similar surgeries.\n\nParticipation in the study is completely voluntary. Patients may choose not to participate or may withdraw from the study at any time without affecting the quality of their medical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80\n* American society of Anathesiologist physical status ASA Ior II\n* Patients undergoing Fixation of femur fractures\n\nExclusion Criteria:\n\n1. Refusal of participation in study.\n2. Bleeding disorders (platelets count \\< 80,000, INR \\>1.5, Prothrombin concentration \\< 60%).\n3. Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs.\n4. Known local anesthetic (LA) drug sensitivity. -'}, 'identificationModule': {'nctId': 'NCT06990958', 'briefTitle': 'Comparing Erector Spinae and Fascia Iliaca Blocks for Pain Relief After Femur Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Erector Spinae Plane Block Versus Fascia Iliaca Compartment Block for Analgesia in Proximal and Midshaft Femur Surgeries in Adult Patients: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MS-212-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESPB Group', 'description': 'patients was placed in the lateral position . the block was performed bz ipsilateral injection of a mixture containing 15mls bupivcaine 0,5% and 20mls normal saline.', 'interventionNames': ['Procedure: Erector Spinae Plane Block (ESPB) group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FICB', 'description': 'Patients was placed insupine position . the block performed using a mixture of 15mls bupivcaine 0,5% and 20mls normal saline.', 'interventionNames': ['Procedure: Fascia iliaca compartment block (FICB)']}], 'interventions': [{'name': 'Erector Spinae Plane Block (ESPB) group', 'type': 'PROCEDURE', 'description': 'ultrasound guided erector spinae plane block (at lumbar level) in lateral position .', 'armGroupLabels': ['ESPB Group']}, {'name': 'Fascia iliaca compartment block (FICB)', 'type': 'PROCEDURE', 'description': 'ultrasound guided suprainguinal approach in supine position', 'armGroupLabels': ['FICB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'kasr alainy hospital -Cairo university , cairo', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, surgical ICU and Pain Management Faculty of Medicine, Cairo University', 'investigatorFullName': 'Wissam Ahmed Mohamed El Damacey', 'investigatorAffiliation': 'Cairo University'}}}}