Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-20 @ 12:08 PM
Study NCT ID:
NCT07257757
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fascia Iliaca Compartment Block in Total Knee Arthroplasty With Intra-Articular Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Postoperative 24 hours', 'description': 'The visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."'}], 'secondaryOutcomes': [{'measure': 'Rating levels of satisfaction', 'timeFrame': 'Posoperative 24 hours', 'description': 'A possible scale is then: "Not at all Satisfied," "Partly Satisfied," "Satisfied," "More than Satisfied," "Very Satisfied," numbering 1 to 5 as an interval scale.'}, {'measure': 'Recording of surgical drain output', 'timeFrame': 'Postoperative 24 hours', 'description': 'Monitoring the output from surgical drains is important part of post-operative care. It is a measurement method that allows us to monitor the amount of bleeding in a patient after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative', 'Patient Satisfaction', 'Pain', 'Bleeding', 'Peripheral Nerve Block', 'Continuous Fascia Iliaca Comparment Block', 'Intra-articular Injection'], 'conditions': ['Total Knee Arthroplasty (Postoperative Pain)']}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in total knee arthroplasty cases in addition to intraoperative intra-articular injection.', 'detailedDescription': 'Postoperative pain management is of great importance in orthopedic surgeries. Inadequate analgesia following total knee arthroplasty increases the risk of side effects such as thromboembolism, myocardial ischemia, pulmonary dysfunction, paralytic ileus, urinary retention, and postoperative bleeding, thereby prolonging hospital stays.\n\nRecently, fascia iliaca compartment block (FICB) has been frequently used to treat pain following knee replacement surgery. However, there are only a limited number of studies demonstrating the effectiveness of this method for postoperative analgesia. Sensory innervation of the lower extremity is primarily provided by four main nerves and their branches. These are the sciatic nerve, femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. FICB is a compartment block in which local anesthetic is injected under the iliac fascia to block the femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. The iliac fascia is the second fascial plane encountered when examining the proximal lower extremity with ultrasound (USG), extending immediately beneath the fascia latae. The goal is to place the needle tip under the iliac fascia, a few centimeters away from the femoral artery. Then, a single dose of local anesthetic can be administered under the iliac fascia, or a catheter can be placed in this area with ultrasound guidance.\n\nCocktails containing local anesthetic, narcotic analgesic, epinephrine, methylprednisolone, and cefuroxime are injected periarticularly for the preemptive treatment of pain following knee replacement surgery. This method, one of the multimodal protocols, is used to minimize the use of parenteral narcotics in order to protect against side effects.\n\nRegional blocks are simple techniques that not only improve postoperative pain control but also reduce postoperative opioid requirements, shorten hospital stays, increase patient satisfaction, and lead to better clinical outcomes after total knee arthroplasty.\n\nIn our clinic, continuous fascia iliaca compartment block is applied for postoperative analgesia in total knee arthroplasty cases. The aim of this study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in addition to intraoperative intra-articular injection on postoperative analgesia, postoperative bleeding and patient satisfaction in total knee arthroplasty cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent unilateral total knee arthroplasty at the Orthopedics and Traumatology Clinic of Kırıkkale University Faculty of Medicine Hospital and received postoperative analgesia using different methods', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total knee arthroplasty cases with or without continuous fascia iliaca compartment block\n* Patients with ASA criteria 1-2-3\n\nExclusion Criteria:\n\n* Patients whose records cannot be accessed\n* Patients with ASA criteria 4-5'}, 'identificationModule': {'nctId': 'NCT07257757', 'briefTitle': 'Fascia Iliaca Compartment Block in Total Knee Arthroplasty With Intra-Articular Injection', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'Evaluation of the Analgesic Efficacy of Fascia Iliaca Compartment Block in Patients Undergoing Total Knee Arthroplasty With Intra-Articular Injection: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'KirikkaleU-2024.06.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Total knee arthroplasty cases where only intra-articular injection was performed'}, {'label': 'Continuous Fascia Iliaca Compartment Block Group', 'description': 'Total knee arthroplasty cases in which continuous fascia iliaca compartment block is performed in addition to intra-articular injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71100', 'city': 'Kırıkkale', 'country': 'Turkey (Türkiye)', 'facility': 'Kırıkkale University', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}], 'overallOfficials': [{'name': 'Kevser PEKER, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kırıkkale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Zafer Gün', 'investigatorAffiliation': 'Kırıkkale University'}}}}