Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 2:25 AM
Study NCT ID:
NCT04945668
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2021-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate to target a suggested optimal landmark', 'timeFrame': 'just after skin puncture', 'description': 'Is defined as the percentage of success to reach the target point for injection with needle punctures to up to 4 skin punctures.'}], 'secondaryOutcomes': [{'measure': 'Success rate of first skin puncture', 'timeFrame': 'just after skin puncture', 'description': 'Is defined as the number of getting the target point from the first skin puncture'}, {'measure': 'The number of skin punctures:', 'timeFrame': 'just after skin puncture for the block', 'description': 'Is defined as the total number of skin punctures for either getting the target point or not.'}, {'measure': 'the total number of needle passes required for obtaining the target landmark', 'timeFrame': 'just after skin puncture', 'description': 'Is defined as the total number of forward advancements of the spinal needle i.e. withdrawal and redirection without exiting the skin (sum of passes of all punctures).'}, {'measure': 'The optimum volume of the injectate', 'timeFrame': '30 minutes before surgery.', 'description': 'Is defined as the optimum volume of the injectate to cover the target innervation area.'}, {'measure': 'Pain measurement at rest', 'timeFrame': 'Prior to performing of nerve block, 15, 30 minutes after block performance', 'description': '10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain.'}, {'measure': 'Pain measurement on movement (attempted hip flexion to 15 degrees):', 'timeFrame': 'Prior to performing of nerve block, 15, 30 minutes after block performance', 'description': '10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain,'}, {'measure': 'Incidence of block failed block', 'timeFrame': '30 minutes after Local Anesthetic injection', 'description': 'Is defined as less than 50% pain relief of pain i.e. (less than 50% of VAS score is reduced after the block'}, {'measure': 'Time for first analgesic request', 'timeFrame': 'Within 24 hours after surgery', 'description': 'the time passed from LA injection to the patient need of first analgesia'}, {'measure': 'Patient satisfaction score', 'timeFrame': 'Within 24 hours after the nerve block', 'description': 'From zero=Poor, 1=fair, 2=good, 3=very good to 5=excellent'}, {'measure': 'Complications:', 'timeFrame': 'Within 24 hours after the nerve block', 'description': 'presence or absence of unintentional vascular puncture, hematoma formation, parasthesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care.\n\nA recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.', 'detailedDescription': 'The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.\n\nThe anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.\n\nUltrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.\n\nWith the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I, II, and III.\n* Patients scheduled for elective or emergent hip fractures.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Neuromuscular diseases (as myopathies, myasthenia gravies…)\n* Hematological diseases, bleeding, or coagulation abnormality.\n* Psychiatric diseases.\n* Local skin infection and sepsis at the site of the block.\n* Known intolerance to the study drugs.\n* Body Mass Index \\> 40 Kg/m2.\n* Multiple trauma patients.'}, 'identificationModule': {'nctId': 'NCT04945668', 'briefTitle': 'Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Combined Ultrasound and Fluoroscopy-guided Technique for Treatment of Hip Pain. A Pilot Study for a Suggested Approach for Anterior Hip Denervation', 'orgStudyIdInfo': {'id': 'MFM-IRB, R.21.05.1337'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pericapsular nerve group block', 'description': 'combined ultrasound and fluoroscopy-guided technique for pericapsular nerve group block', 'interventionNames': ['Procedure: Modified technique for pericapsular nerve group block']}], 'interventions': [{'name': 'Modified technique for pericapsular nerve group block', 'type': 'PROCEDURE', 'description': 'with the patient in the supine position, ultrasound probe in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus. In this view, the ilio pubic eminence (IPE), the iliopsoas muscle and tendon will be observed. A spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip between the psoas tendon and the pubic ramus. Fluoroscopic image will be taken to confirm the needle tip position in the target site. Following negative aspiration, 15 ml dye will be injected in 5-mL increments while observing for adequate spread using fluoroscopy followed by 15ml local anesthetic', 'armGroupLabels': ['Pericapsular nerve group block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed Y Makharita, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Anesthesia and Surgical Intensive Care'}, {'name': 'Shimaa Shalaby, M.Sec.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer of Anesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'after completing the study and being accepted for publication.', 'ipdSharing': 'YES', 'accessCriteria': 'The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}