Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-21 @ 3:15 AM
Study NCT ID:
NCT04638569
Status:
UNKNOWN
Last Update Posted:
2022-02-07
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-28', 'releaseDate': '2023-10-03'}, {'resetDate': '2024-09-11', 'releaseDate': '2024-04-22'}, {'resetDate': '2025-05-19', 'releaseDate': '2025-05-05'}], 'estimatedResultsFirstSubmitDate': '2023-10-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-24', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative succesful obturator nerve block', 'timeFrame': 'operation time', 'description': 'peroperative adductor muscle spazm'}], 'secondaryOutcomes': [{'measure': 'peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month', 'timeFrame': '3 months', 'description': 'peroperative bledding, Control by cystoscopy in the postoperative 3rd month recurrence tumor size'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obturator nerve block', 'bladder tumor', 'ultrasonografi', 'anatomical signs'], 'conditions': ['Succesful Obturator Nerve Block', 'Bladder Tumor', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.', 'detailedDescription': 'The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II patients\n\nExclusion Criteria:\n\n* Tumors that disrupt the integrity of the bladder,\n* bladder floor tumors,\n* coagulation disorders,\n* motor in the lower limbs\n* with sensory disturbances,\n* uncooperative patients,\n* Known allergy to local anesthetics\n* patients with localized infection at the procedure site'}, 'identificationModule': {'nctId': 'NCT04638569', 'briefTitle': 'Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection', 'orgStudyIdInfo': {'id': '27/12/2019-19/VIII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided obturator nerve block group', 'description': 'The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle.', 'interventionNames': ['Procedure: obturator nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'obtutaror nerve block with anatomical landmarks', 'description': 'In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL.', 'interventionNames': ['Procedure: obturator nerve block']}], 'interventions': [{'name': 'obturator nerve block', 'type': 'PROCEDURE', 'description': 'The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. The time elapsed until the first needle insertion and local anesthetic injection is completed will be recorded as the application time.', 'armGroupLabels': ['Ultrasound-guided obturator nerve block group', 'obtutaror nerve block with anatomical landmarks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eylem Yaşar, MD', 'role': 'CONTACT', 'email': 'eylemtarakci@gmail.com', 'phone': '00905332392622'}], 'facility': 'Mugla Sitki Kocman University', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'centralContacts': [{'name': 'Eylem Yasar, MD', 'role': 'CONTACT', 'email': 'eylemtarakci@gmail.com', 'phone': '00905332392622'}, {'name': 'eylem yasar', 'role': 'CONTACT', 'email': 'eylemtarakci@gmail.com'}], 'overallOfficials': [{'name': 'Eylem Yaşar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}, {'name': 'Ali İhsan Uysal', 'role': 'STUDY_CHAIR', 'affiliation': 'Mugla Sitki Kocman University Department of Anesthesia'}, {'name': 'İlker Akarken', 'role': 'STUDY_CHAIR', 'affiliation': 'Mugla Sitki Kocman University Department of Urology'}, {'name': 'basak altiparmak', 'role': 'STUDY_CHAIR', 'affiliation': 'Mugla Sitki Kocman University Department of Anesthesia'}, {'name': 'semra demirbilek', 'role': 'STUDY_CHAIR', 'affiliation': 'Mugla Sitki Kocman University Department of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor of anesthesiology special', 'investigatorFullName': 'Eylem Yaşar', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-03', 'type': 'RELEASE'}, {'date': '2024-03-28', 'type': 'RESET'}, {'date': '2024-04-22', 'type': 'RELEASE'}, {'date': '2024-09-11', 'type': 'RESET'}, {'date': '2025-05-05', 'type': 'RELEASE'}, {'date': '2025-05-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eylem Yaşar, medical doctor of anesthesiology special, Muğla Sıtkı Koçman University'}}}}