Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-26 @ 10:13 PM
Study NCT ID:
NCT06498557
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2024-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesis in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-06-29', 'studyFirstSubmitQcDate': '2024-07-06', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'postoperative 24 hours', 'description': 'Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'inflammatory mediators', 'timeFrame': 'preoperative 24 hours', 'description': 'NLR'}, {'measure': 'inflammatory mediators', 'timeFrame': 'preoperative 24 hours', 'description': 'PLR'}, {'measure': 'inflammatory mediators', 'timeFrame': 'preoperative 24 hours', 'description': 'SII'}, {'measure': 'inflammatory mediators', 'timeFrame': 'preoperative 24 hours', 'description': 'Lactate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POSTOPERATIVE PAIN', 'Knee Arthroplasty'], 'conditions': ['Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Postoperative analgesic treatment methods are applied to patients who have undergone knee arthroplasty. These applications are a routine part of the procedure. It is medically and ethically necessary. Postoperative analgesia applications are started during the intraoperative period and continued during the postoperative period. The analgesia protocol to be used is shaped by the characteristics of the patient and the skill and experience of the anesthesiologist. The scientifically accepted method is multimodel analgesia protocols. These protocols cover a wide range from paracetamol to opioids to peripheral and central blocks (methods such as suprainguinal fascia iliac block (SFIP), adductor block (ACB) and infiltration analgesia (IPACK) applied between the posterior elements of the knee and the popliteal artery). Our aim in this study is to evaluate the effects of analgesia protocols applied to patients undergoing knee arthroplasty surgery on inflammatory biomarkers (such as neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII), lactate) obtained from routine blood and blood gas examinations in the first 24 hours of the postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among patients who had elective knee replacement surgery, those who underwent postoperative nerve block', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old\n* ASA I,II,III patients\n* Patients who will undergo elective surgery\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n* Patients with bleeding diathesis\n* Those who are allergic or sensitive to local anesthetics and opioid drugs,\n* Those who use gabapentinoids\n* Patients with neurocognitive disorders,\n* Patients with chronic organ failure,\n* Mothers with suspected pregnancy, pregnant or breastfeeding mothers\n* Patients using opioids\n* Those who use steroids\n* Those with a history of substance use'}, 'identificationModule': {'nctId': 'NCT06498557', 'briefTitle': 'Postoperative Analgesis in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Samsun University'}, 'officialTitle': 'Results of Postoperative Analgesis Protocols Applied in Total Knee Arthroplasty:Observational Study', 'orgStudyIdInfo': {'id': 'GOKAEK 2024/10/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group S', 'description': 'SFIP block will be applied for postoperative analgesic purposes', 'interventionNames': ['Other: Peripheral nerve block methods']}, {'label': 'Group IP', 'description': 'SFIP block will be applied for postoperative analgesic purposes', 'interventionNames': ['Other: Peripheral nerve block methods']}], 'interventions': [{'name': 'Peripheral nerve block methods', 'type': 'OTHER', 'description': 'We apply different nerve blocks to patients for analgesic purposes after knee replacement surgery. These blocks are a combination of SFIP block and adductor channel block and iPACK block.', 'armGroupLabels': ['Group IP', 'Group S']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'SAMSUN UNIVERSITY Samsun Training and research hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Senay canikli adıgüzel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsun University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Participants' data will not be shared. After the study is written as an article, it can be shared if the editor of the journal wishes"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Senay Canikli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Senay Canikli', 'investigatorAffiliation': 'Samsun University'}}}}