Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05913167
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not know which block was administered outcome assessors will not know which block was administered'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'erector spina and transversus abdominis plane blocks'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morphine consumption', 'timeFrame': '24 hour postoperatively', 'description': 'morphine patient controlled analgesia was applied to the patients'}], 'secondaryOutcomes': [{'measure': 'Peroperative remifentanil consumptions', 'timeFrame': 'peroperatively', 'description': 'continious remifentanil infusion was applied'}, {'measure': 'postoperative analgesia numeric rating scales', 'timeFrame': 'postoperative 24 hours', 'description': 'patients will give numbers to their pain first hour, 6th hour and 24 th hour after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopy', 'nephrectomy', 'erector spina plan block', 'transversus abdominis plan block', 'morphine consumption', 'analgesia'], 'conditions': ['Laparoscopic Nephrectomy']}, 'descriptionModule': {'briefSummary': 'Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.', 'detailedDescription': 'Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 age\n* patients undergoing laparoscopic nephrectomy\n* ASA 1-3\n\nExclusion Criteria:\n\n* \\<18- \\>65 \\< age\n* patients undergoing open nephrectomy\n* ASA 4-5'}, 'identificationModule': {'nctId': 'NCT05913167', 'briefTitle': 'Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of Erector Spina and Transversus Abdominus Plan Blocks', 'orgStudyIdInfo': {'id': 'LAPNEF2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spina plan block', 'description': 'Erector spina plan block will be administered to the patients in this group.', 'interventionNames': ['Procedure: laparoscopic nephrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus abdominis plan block', 'description': 'Transversus abdominis plan block will be administered to the patients in this group.', 'interventionNames': ['Procedure: laparoscopic nephrectomy']}], 'interventions': [{'name': 'laparoscopic nephrectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic nephrectomy', 'armGroupLabels': ['Erector spina plan block', 'Transversus abdominis plan block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zehra Ipek ARSLAN, Associate Professor', 'role': 'CONTACT', 'email': 'zehraipek48@gmail.com', 'phone': '00905325011339'}, {'name': 'Zehra I ARSLAN, Associate Professor', 'role': 'CONTACT'}], 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'centralContacts': [{'name': 'Zehra Arslan', 'role': 'CONTACT', 'email': 'zehraipekarslan@hotmail.com', 'phone': '0090303', 'phoneExt': '8168'}, {'name': 'Zehra Arslan', 'role': 'CONTACT', 'email': 'zehraipekarslan@hotmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}