Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 9:30 AM
Study NCT ID:
NCT06245460
Status:
TERMINATED
Last Update Posted:
2025-11-24
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation by Ultrasound Imaging of Local Anesthetic Spread to the Popliteal Fossa During an Adductor Canal Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal investigator want to stop the study then begining another new one', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Frequency of local anesthetic's spread", 'timeFrame': 'at baseline', 'description': "The primary outcome is the frequency of local anesthetic's spread to tibial and fibular nerve during an adductor canal block, assessed by ultrasound imaging at the popliteal fossa level. The ultrasound images will be recorded and then assessed by two independent anesthesiologists."}], 'secondaryOutcomes': [{'measure': 'Frequency of altered sensibility', 'timeFrame': 'at one and four hours', 'description': 'Frequency of altered sensibility and motricity in fibular and tibial nerves territories assessed at one and four hours after the adductor canal block has been performed.'}, {'measure': 'Correlation between local anesthetic spread and clinical alteration', 'timeFrame': 'at baseline, hour 1 and hour 4th', 'description': "Correlation between local anesthetic spread to tibial and fibular nerves during adductor canal block assessed by ultrasound imaging and clinical alteration of sensibility and motricity in these nerves' territories."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee surgery', 'ultrasound', 'analgesia', 'pain'], 'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': "Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. However this diffusion's frequency has never been measured. The main objective of this study is to assess the frequency of the spread of the adductor canal block to the fibular and tibial nerves assessed by ultrasound observation at the popliteal fossa.", 'detailedDescription': "Adductor canal block is an effective analgesic technique for major knee surgery. The PROSPECT group recommends this block in first intention for locoregional anesthesia in total knee arthroplasty. It has been shown to not be inferior to femoral nerve block in this indication.\n\nThe adductor canal block targets the saphenous nerve and, through its spread in the adductor canal, the posterior branch of obturator nerve and the vastus medialis nerve. However these nerves can't fully explain this block's efficiency.\n\nIt has been shown that local anesthetic can spread in the adductor canal to the tibial and fibular nerves through the adductor hiatus. However, this spread is inconstant, and no study has evaluated the frequency of this spread yet.\n\nThe main objective of this study is to assess the diffusion's frequency of adductor canal block to fibular and tibial nerves through ultrasound observation at the popliteal fossa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be all the consecutive patients scheduled for elective knee surgery under general anesthesia in our center and receiving an adductor canal block.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for elective knee surgery under general anesthesia\n* in center of Ambroise Paré hospital\n* receiving an adductor canal block\n\nExclusion Criteria:\n\n* patients cognitively impaired\n* patients suffering from peripheral neuropathy at the lower limb\n* patients receiving an IPACK block or surgical knee infiltration to complete the adductor canal block analgesia\n* patients who refused to take part in this study\n* pregnant or breastfeeding patients\n* patients under guardianship\n* imprisoned patients\n* patients without any medical insurance'}, 'identificationModule': {'nctId': 'NCT06245460', 'acronym': 'EchoCAdd', 'briefTitle': 'Evaluation by Ultrasound Imaging of Local Anesthetic Spread to the Popliteal Fossa During an Adductor Canal Block', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation by Ultrasound Imaging of Local Anesthetic Spread to the Popliteal Fossa During an Adductor Canal Block', 'orgStudyIdInfo': {'id': 'APHP231771'}, 'secondaryIdInfos': [{'id': '2023-A01774-41', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Department of anesthesia, Ambroise Paré Hospital - APHP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'overallOfficials': [{'name': 'Romuald Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of anesthesia, Ambroise Paré Hospital - APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}