Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-28 @ 2:15 PM
Study NCT ID:
NCT05009550
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Scale assesment', 'timeFrame': '24 hours after procedure', 'description': 'A research assistant, blinded to the group allocation, interviewed patients and collected data at 6 times intervals (0.,2.,4.,6.,12 and 24 hours) in the 24 hours postprocedure. Patients will be asked to rate their pain using Numeric Pain Scale, where 0=no pain and 10=worst pain possible.'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': '24 hours after procedure', 'description': 'Age, BMI, ASA, Duration of procedure are recorded.'}, {'measure': 'Incidences of adverse effects (like nausea and vomiting)', 'timeFrame': '24 hours after procedure', 'description': 'Incidences of adverse effects (like nausea and vomitting) during the 24 hours postprocedure perİod is recorded at 6 times intervals (0,2,4,6,12,24 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector spinae block', 'Radiofrequency ablation', 'Hepatocellular Carcinomas', 'ultrasound'], 'conditions': ['Hepatic Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26321447', 'type': 'RESULT', 'citation': 'Wells SA, Hinshaw JL, Lubner MG, Ziemlewicz TJ, Brace CL, Lee FT Jr. Liver Ablation: Best Practice. Radiol Clin North Am. 2015 Sep;53(5):933-71. doi: 10.1016/j.rcl.2015.05.012.'}, {'pmid': '26266387', 'type': 'RESULT', 'citation': 'Joung KW, Choi SS, Jang DM, Kong YG, Lee HM, Shim JH, Won HJ, Shin YM, Kim PN, Song MH. Comparative Effects of Dexmedetomidine and Propofol on US-Guided Radiofrequency Ablation of Hepatic Neoplasm Under Monitored Anesthesia Care: A Randomized Controlled Study. Medicine (Baltimore). 2015 Aug;94(32):e1349. doi: 10.1097/MD.0000000000001349.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the ability of Erector spina Plane Block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.', 'detailedDescription': 'Erector spina Plane Block is performed with guided ultrasound at T8 transverse process level lead to adequate intraprocedural and postoperative analgesia, in percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II patients\n\nExclusion Criteria:\n\n* history of allergy to the study medication\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT05009550', 'briefTitle': 'ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Effect of Erector Spina Plain (ESP) Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation', 'orgStudyIdInfo': {'id': '2021/346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block group (ESP)', 'description': 'Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group. Then standard sedation method is applied to all patients.', 'interventionNames': ['Procedure: Group ESP']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'This Group was received no intervention.Standard sedation method is applied to all patients.', 'interventionNames': ['Other: Non-blocked Group']}], 'interventions': [{'name': 'Group ESP', 'type': 'PROCEDURE', 'description': 'Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group', 'armGroupLabels': ['Erector spinae plane block group (ESP)']}, {'name': 'Non-blocked Group', 'type': 'OTHER', 'description': 'This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38090', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Özlem Öz Gergin, MD', 'role': 'CONTACT', 'email': 'oozgergin@erciyes.edu.tr', 'phone': '09005332466396'}], 'facility': 'Özlem Öz Gergin', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Özlem OZ Gergin, MD', 'role': 'CONTACT', 'email': 'oozgergin@erciyes.edu.tr', 'phone': '09005332466396'}, {'name': 'Özlem OZ Gergin, professor', 'role': 'CONTACT', 'email': 'oozgergin@erciyes.edu.tr', 'phone': '09005332466396'}], 'overallOfficials': [{'name': 'Ozlem Oz Gergin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 24 months of study completion', 'ipdSharing': 'YES', 'description': 'De- identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Özlem ÖZ GERGİN', 'investigatorAffiliation': 'TC Erciyes University'}}}}