Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06942702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Genicular Block on Total Knee Arthroplasty Surgery
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': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale Measure', 'timeFrame': '0-48 hours', 'description': 'VAS scores are assessed at 0th, 24th and 48th hours post operatively VAS score consists of 0-10 in numbers, the bigger the number the worse the pain'}, {'measure': 'opioid consumption', 'timeFrame': '0-48 hours', 'description': 'Morphine consumption is assesed by PCA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'genicular block', 'postoperative pain'], 'conditions': ['Total Knee Anthroplasty', 'Genicular Nerves Block']}, 'referencesModule': {'references': [{'pmid': '21609599', 'type': 'BACKGROUND', 'citation': 'Wang T, Leng YF, Zhang Y, Kang YQ, Xue X, Zhang Y. [Preventive effects of ischemic postconditioning and penehyclidine hydrochloride on gastric against ischemia-reperfusion injury in rats]. Zhonghua Yi Xue Za Zhi. 2011 Apr 26;91(16):1130-5. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the postoperative pain relieving effect of preoperative genicular block in total knee arthroplasty surgery. The main questions it aims to answer are:\n\n1. Do visual analog scale (VAS) scores decrease in patients who underwent geniculate block?\n2. Does opioid consumption decrease in patients who underwent geniculate block?\n\nResearchers will compare postoperative pain in patients who received genicular block with those who did not.One group of patients will be administered 0.25% bupivacaine with the geniculate block method. The other group will not undergo any intervention. Both groups will be administered intravenous morphine for postoperative analgesia.', 'detailedDescription': 'Patients scheduled for knee arthroplasty will be randomly assigned into two groups. One group will receive a genicular nerve block prior to surgery without the administration of general anesthesia, while the other group will not undergo any interventional procedure. The genicular nerve block will be administered in three quadrants around the knee, with each injection consisting of 5 mL of 0.25% Marcaine. All injections will be performed by investigator MA. Patient assessments will be conducted by investigator MO. Postoperative intravenous analgesia will be provided to both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for unilateral and primary total knee arthroplasty\n* Older than 18 years of age\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Bilateral knee arthroplasty\n* Revision case of knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT06942702', 'briefTitle': 'Efficacy of Genicular Block on Total Knee Arthroplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Assesment of Postoperative Analgesic Efficacy of Preoperatively Applied Genicular Block on Total Knee Arthroplasty: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MersinUgenicular'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Genicular block group', 'description': 'this group consists of the patients receiving genicular block preoperatively and they will be given morfin with PCA (Patient controlled analgesia) and paracetamol 3x1000 mg intravenous and diclofenac 75 mg intramuscular (if needed)', 'interventionNames': ['Drug: Genicular blocks (bupivakain)', 'Drug: Patient Control Analgesia (PCA) Morphine group', 'Drug: Paracetamol (acetaminophen) + Diclofenac Sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients only given PCA-morfin postoperatively', 'description': 'this group consists of the patients given morfin with PCA, paracetamol 3x1000 mg and diclofenac (if needed)', 'interventionNames': ['Drug: Patient Control Analgesia (PCA) Morphine group', 'Drug: Paracetamol (acetaminophen) + Diclofenac Sodium']}], 'interventions': [{'name': 'Genicular blocks (bupivakain)', 'type': 'DRUG', 'description': 'Genicular block is a regional analgesic technique performed with USG', 'armGroupLabels': ['Genicular block group']}, {'name': 'Patient Control Analgesia (PCA) Morphine group', 'type': 'DRUG', 'otherNames': ['PCA-M'], 'description': 'this group consists of the patients no any intervention preoperatively and they will be given morfin with PCA (Patient controlled analgesia) and paracetamol 3x1000 mg intravenous and diclofenac 75 mg intramuscular (if needed)', 'armGroupLabels': ['Genicular block group', 'patients only given PCA-morfin postoperatively']}, {'name': 'Paracetamol (acetaminophen) + Diclofenac Sodium', 'type': 'DRUG', 'description': 'All patients are given paracetamol (3x1000 mg) and diclofenac (if needed)', 'armGroupLabels': ['Genicular block group', 'patients only given PCA-morfin postoperatively']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mustafa Azizoglu, Associated Professor', 'role': 'CONTACT', 'email': 'dryalamaoglu@hotmail.com', 'phone': '+90 5325667061'}, {'name': 'Mervenur Ozturk, Resident Doctor', 'role': 'CONTACT', 'email': 'mervenurnurozturk@gmail.com', 'phone': '+90 5525345189'}], 'overallOfficials': [{'name': 'Mustafa Azizoglu, Associated Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin university Faculty of Medicine, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data (IPD) will not be shared due to ethical considerations and institutional policies on patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Mustafa Azizoğlu', 'investigatorAffiliation': 'Mersin University'}}}}