Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-04-17 @ 9:40 AM
Study NCT ID:
NCT05526794
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Methods on Percutaneous Kyphoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Visual Analog Scala (VAS) values', 'timeFrame': 'VAS values at postoperative 24 hours', 'description': 'VAS is a scala between 0-10 points. If there is no pain it means 0; very severe pain is 10 points.'}], 'secondaryOutcomes': [{'measure': 'Analgesic consumption', 'timeFrame': 'postoperative 24 hours after surgery', 'description': 'In all times that VAS is recorded;1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['percutan kyphoplasty', 'Vertebroplasty'], 'conditions': ['Vertebral Fracture']}, 'descriptionModule': {'briefSummary': "The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP).\n\nMethod: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block \\[Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)\\]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).", 'detailedDescription': "Demographic characteristics (body mass index \\[BMI\\], gender, age, ASA use, pain values \\[VAS\\] before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol? or anesthetic need, perioperative complications \\[patients who willingly stopped the procedure during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory depression, desaturation and need for mask ventilation\\] were taken from the records of the individuals with the treatment of PKP between 01/22-07/22 after the approval of the SBÜ Bursa Yüksek İhtisas EAH Ethics Committee (2021-KAEK-25 2021/12-09) and the patient's consent. In addition, the first mobilization time, additional analgesic need, total amount of analgesic used in 24 hours, discharge time, VAS values at 2, 6,12, and 18 hours, complications (nausea, vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis, pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator) were also recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18-100 aged kyphoplasty patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-100 ages kyphoplasty surgery patients\n* written consent form received\n\nExclusion Criteria:\n\n* The patient's unwillingness to participate in the study\n* inability to communicate with the patient\n* the patient does not speak Turkish,\n* previous CVO, presence of cognitive impairment"}, 'identificationModule': {'nctId': 'NCT05526794', 'briefTitle': 'Anesthesia Methods on Percutaneous Kyphoplasty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study', 'orgStudyIdInfo': {'id': '2021-KAEK-25 2021/12-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'General anesthesia or sedation', 'interventionNames': ['Procedure: Analgesic consumption']}, {'label': 'Group 2', 'description': 'Central Block (Spinal and Epidural Anesthesia', 'interventionNames': ['Procedure: Analgesic consumption']}, {'label': 'Group 3', 'description': 'Peripheral Block \\[Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)', 'interventionNames': ['Procedure: Analgesic consumption']}], 'interventions': [{'name': 'Analgesic consumption', 'type': 'PROCEDURE', 'description': '1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16600', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Tuğba T Onur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Ümran Ü Karaca, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Asiye A Demirel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Şeyda Efsun ŞE Özgünay, Assoc Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Anıl A Onur, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Medicabil Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'With the written consent of the patients and the approval of the ethics committee, I do not intend to share their special circumstances and information other than the study data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Tugba Onur', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}