Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 3:07 AM
Study NCT ID:
NCT04286035
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2020-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tramadol consumption', 'timeFrame': '24 hours after operation', 'description': 'Postoperative tramadol consumption with patient controlled analgesia'}, {'measure': 'VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain)', 'timeFrame': '24 hours after operation', 'description': 'VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia'}, {'measure': 'Rescue analgesic requirement', 'timeFrame': '24 hours after operation', 'description': 'If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': '24 hours after operation', 'description': 'Frequency of postoperative nausea and vomiting'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['femoral nerve block, adductor canal block, total knee arthroplasty'], 'conditions': ['Knee Replacement, Total', 'Pain, Postoperative', 'Anesthesia, Regional']}, 'descriptionModule': {'briefSummary': 'The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA(American Society of Anesthesiologists) Classification I-II\n* Age: \\<55 years\n* Unilateral total knee arthroplasty\n\nExclusion Criteria:\n\n* Does not approve the study\n* Pregnant\n* Emergency\n* ASA III-IV\n* History of local anesthetic allergy\n* Infection in the block area\n* Coagulation disorder\n* Morbid obesity (body mass index\\> 40 kg / m²)\n* Severe organ failure\n* Previous neurological deficit\n* Psychiatric disease\n* History of chronic pain'}, 'identificationModule': {'nctId': 'NCT04286035', 'briefTitle': 'Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effects of Femoral Nerve Block and Adductor Canal Block on Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'SK01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral group', 'interventionNames': ['Drug: Bupivacaine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor group', 'interventionNames': ['Drug: Bupivacaine Injection']}], 'interventions': [{'name': 'Bupivacaine Injection', 'type': 'DRUG', 'description': 'Femoral nerve block with 20 ml %0.375 bupivacaine', 'armGroupLabels': ['Femoral group']}, {'name': 'Bupivacaine Injection', 'type': 'DRUG', 'description': 'Adductor canal block with 20 ml %0.375 bupivacaine', 'armGroupLabels': ['Adductor group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Kerim Şahin', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}