Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-27 @ 1:52 PM
Study NCT ID:
NCT06088368
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2023-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block application time', 'timeFrame': 'up to 20 minutes', 'description': 'The stopwatch will be started by another researcher with the needle skin penetration and the stopwatch will be stopped as soon as the needle leaves the skin.'}], 'secondaryOutcomes': [{'measure': 'Number of interventions', 'timeFrame': 'up to 20 minutes', 'description': 'intervention from the same or another site after exiting the skin'}, {'measure': 'The number of needle guidance', 'timeFrame': 'up to 20 minutes', 'description': 'Retraction and re-advancement of the needle after skin entry without exiting the skin'}, {'measure': 'sensory block', 'timeFrame': 'up to 40 minutes', 'description': 'Both lower limbs sensory block time after the applied block will be evaluated by pinprick and cold test (10.15., 20., 25., 30., 35. and 40 minutes).'}, {'measure': 'motor block', 'timeFrame': 'up to 40 minutes', 'description': "Both lower limbs Modified Bromage scale was used to evaluate motor block. Modified Bromage scale 0 No motor block\n\n1. Raises the knee in flexion\n2. Raises the ankle\n3. Full block, can't move his foot"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femoral Neck Fractures', 'Lumbosacral Plexus', 'Nerve Block']}, 'descriptionModule': {'briefSummary': 'The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.', 'detailedDescription': 'The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-90 years old\n* ASA (American Society of Anaesthesiologist) Score I-III risk class\n* Patients who will undergo femoral neck fracture operation.\n\nExclusion Criteria:\n\n* Local Anaesthetic Allergy\n* With Bleeding Diathesis Disorder\n* Mental Disorders\n* Allergic to the medicines used\n* Previous Cerebrovascular Disease\n* Body Mass Index above 30'}, 'identificationModule': {'nctId': 'NCT06088368', 'briefTitle': 'Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Investigation of the Efficacy of Different Types of Lumbar Plexus Block Applied With Ultrasound-guided Shamrock Method', 'orgStudyIdInfo': {'id': '2023-3/7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'in-plane needle guidance', 'description': 'Ultrasound -guided lumbar plexus block', 'interventionNames': ['Procedure: in-plane needle guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'out-of-plane needle guidance', 'description': 'Ultrasound -guided lumbar plexus block', 'interventionNames': ['Procedure: out-of-plane needle guidance']}], 'interventions': [{'name': 'in-plane needle guidance', 'type': 'PROCEDURE', 'description': 'Ultrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method', 'armGroupLabels': ['in-plane needle guidance']}, {'name': 'out-of-plane needle guidance', 'type': 'PROCEDURE', 'description': 'Ultrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method', 'armGroupLabels': ['out-of-plane needle guidance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'centralContacts': [{'name': 'Korgün Ökmen, Assoc. PhD.', 'role': 'CONTACT', 'email': 'korgunokmen@gmail.com', 'phone': '+902242955000'}], 'overallOfficials': [{'name': 'Korgün Ökmen, Assoc. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}