Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 9:58 AM
Study NCT ID:
NCT04692857
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-02', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in pain score on movement', 'timeFrame': 'before and 30 minutes after block placement', 'description': 'change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement'}], 'secondaryOutcomes': [{'measure': 'change in pain score at rest', 'timeFrame': 'before and 30 minutes after block placement', 'description': 'change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) at rest, before and 30 minutes after block placement'}, {'measure': 'assessement of sensory block', 'timeFrame': '30 minutes after block placement', 'description': 'sensory assessment of Femoral nerve , obturator nerve, and lateral femoral cutaneous nerve using the cold test . in the anterior , medial and lateral aspects of the thigh.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.\n\nfor group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected', 'detailedDescription': 'participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.\n\nA linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .\n\npain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .\n\nExclusion Criteria:\n\n* inability or refusal to sign informed consent\n* younger than 65 years\n* BMI greater than 35 kg/m²\n* presence of contraindications for regional nerve block or spinal anesthesia\n* impaired cognition or dementia\n* multiple fractures'}, 'identificationModule': {'nctId': 'NCT04692857', 'briefTitle': 'US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia', 'orgStudyIdInfo': {'id': 'UTEM VOL FIBSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 30', 'description': 'participants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine', 'interventionNames': ['Procedure: supra inguinal fascia iliaca block']}, {'type': 'EXPERIMENTAL', 'label': 'group 40', 'description': 'participants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine', 'interventionNames': ['Procedure: supra inguinal fascia iliaca block']}, {'type': 'EXPERIMENTAL', 'label': 'group 50', 'description': 'participants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine', 'interventionNames': ['Procedure: supra inguinal fascia iliaca block']}], 'interventions': [{'name': 'supra inguinal fascia iliaca block', 'type': 'PROCEDURE', 'description': 'injection of 30,40 or 50 ml of 0.2 ropivacaine .', 'armGroupLabels': ['group 30', 'group 40', 'group 50']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Nabeul', 'state': 'Mrezga', 'country': 'Tunisia', 'facility': 'Mechaal Benali', 'geoPoint': {'lat': 36.45606, 'lon': 10.73763}}], 'overallOfficials': [{'name': 'mechaal benali, PROFESSOR', 'role': 'STUDY_CHAIR', 'affiliation': 'university manar Tunis tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Mechaal Benali', 'investigatorAffiliation': 'University Tunis El Manar'}}}}