Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-06 @ 5:05 PM
Study NCT ID:
NCT06201195
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-12-29', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS (visuel analouge scale)', 'timeFrame': 'postblock 3 hour,10 hour, 24 hour', 'description': "for postoperative pain evaluation after TKA surgery. The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end."}, {'measure': 'drain place pain', 'timeFrame': 'postblock 3 hour,10 hour, 24 hour', 'description': 'do you have any pain on drain place? yes or no'}], 'secondaryOutcomes': [{'measure': 'VAS movement', 'timeFrame': 'postblock 3 hour,10 hour, 24 hour', 'description': "Postoperative pain with knee moves evaluate with VAS, The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end."}, {'measure': 'motor strenght', 'timeFrame': 'postblock 3 hour,10 hour, 24 hour', 'description': 'leg elevation and plantar flexion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior femoral cutaneus nerve block', 'distal adductor canal block', 'total knee arthroplasthy'], 'conditions': ['Pain Measurement', 'Knee Replacement Arthroplasty', 'Nerve Block']}, 'referencesModule': {'references': [{'pmid': '31826920', 'type': 'BACKGROUND', 'citation': 'Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty.\n\nThe goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty.\n\nThe main questions it aims to answer are:\n\n* question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?\n* question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?', 'detailedDescription': 'Patients with American Society of Anesthesiologists classification status I-III scheduled for elective primary TKA using standard spinal anesthesia enroll for this trial. After surgery patient divided two groups: 1- adductor canal blockade 2- distal adductor canal blockade + anterior femoral cutaneus nerve blockade. At postoperative 3th, 10th, 24th hour VAS (visuel analouge scale), VAS move, incision plase pain-for top and down of patella, drain place pain, motor strenght for femoral nerve and siyatic nerve, first analjesic requirement time, opioid consumption, total analcesic requirement will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total knee artroplasty\n* Spinal anesthesia\n* ASA 1-3\n\nExclusion Criteria:\n\n* Bupivacaine allergy\n* Coagulopathy\n* Infection on injection site'}, 'identificationModule': {'nctId': 'NCT06201195', 'briefTitle': 'Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Contribution of Anterior Femoral Cutaneous Nerve Block to Postoperative Analgesia for Total Knee Replacement', 'orgStudyIdInfo': {'id': 'AEŞH-EK1-2023-556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor canal block', 'description': 'Usg guidance adductor canal block with %0.25 Bupivacaine 20 ml', 'interventionNames': ['Procedure: Adductor canal blockade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distal adductor canal block with anterior cutaneus nerve block', 'description': 'Usg guidance distal adductor canal block (%0.25 Bupivacaine 20 ml) with anterior cutaneus nerve block (%0.25 Bupivacaine 10 ml)', 'interventionNames': ['Procedure: Distal adductor canala blockade and anterior cutaneus nerve blockade']}], 'interventions': [{'name': 'Adductor canal blockade', 'type': 'PROCEDURE', 'otherNames': ['first control'], 'description': 'VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics', 'armGroupLabels': ['Adductor canal block']}, {'name': 'Distal adductor canala blockade and anterior cutaneus nerve blockade', 'type': 'PROCEDURE', 'otherNames': ['study group'], 'description': 'VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics', 'armGroupLabels': ['Distal adductor canal block with anterior cutaneus nerve block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Derya Ozkan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Principal Investigator Ankara Etlik City Hospital'}, {'name': 'Müge Çakırca, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator Ankara Etlik City Hospital'}, {'name': 'Funda Atar, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Study Principal Investigator Ankara Etlik City Hospital'}, {'name': 'Serhan ünlü, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Study Principal Investigator Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'derya özkan', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}