Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05587166
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Oblique Short-Axis Adductor Canal Block.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catheter placement time (minutes)', 'timeFrame': 'starting from time of syringe removal from placement needle to time of complete threading of the catheter at 20-cm mark measured in minutes and over 20 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adductor Canal Block']}, 'descriptionModule': {'briefSummary': 'The ideal pain management for knee surgery should provide excellent analgesia while minimizing opioid consumption and allowing early mobilization and rehabilitation.\n\nThe use of the continuous technique in ACB allows the delivery of a larger quantity of local anaesthetic into the adductor canal than in the single-shot technique.\n\nThe usual approach for ultrasound-guided ACB catheter insertion is through short-axis in-plane approach in which the ultrasound transducer is applied horizontally over the femoral artery and saphenous nerve. In this approach, the catheter is inserted through a 90-degree angulation with the nerve which might make the catheter insertion difficult.\n\nIn the new oblique position, the catheter will be inserted in a less than 90-degree angulation. This study speculates that decreasing the angle of catheter insertion will make catheter insertion easier and faster.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients more than 18 years\n* ASA I-III\n* scheduled for unilateral knee surgery under spinal anesthesia with an adductor canal perineural catheter planned for postoperative pain control\n\nExclusion Criteria:\n\n* Patient who had an allergy to any drug used in the study\n* Patients with neuropathy of any etiology in the affected extremity, hepatic or renal failure.\n* pregnant females\n* Patients who are unable to communicate with the investigators and hospital staff'}, 'identificationModule': {'nctId': 'NCT05587166', 'briefTitle': 'Ultrasound-Guided Oblique Short-Axis Adductor Canal Block.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound-Guided Oblique Short-Axis Adductor Canal Block: Can the Oblique Approach Facilitate Perineural Catheter Insertion: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD-63-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The transverse short-axis group', 'interventionNames': ['Other: ultrasound guided adductor canal block']}, {'type': 'EXPERIMENTAL', 'label': 'The oblique short-axis group:', 'interventionNames': ['Other: ultrasound guided adductor canal block']}], 'interventions': [{'name': 'ultrasound guided adductor canal block', 'type': 'OTHER', 'description': 'ultrasound-guided adductor canal block using oblique short-axis for catheter insertion', 'armGroupLabels': ['The oblique short-axis group:', 'The transverse short-axis group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abeer Ahmed', 'role': 'CONTACT', 'email': 'abeer_ahmed@kasralainy.edu.eg', 'phone': '01005244590'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Abeer Ahmed, MD', 'investigatorAffiliation': 'Cairo University'}}}}