Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT06410820
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of the first puncture', 'timeFrame': '30 minute', 'description': 'Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.'}], 'secondaryOutcomes': [{'measure': 'Number of skin punctures', 'timeFrame': '30 minute', 'description': 'Skin puncture is defined as any separate skin puncture attempt.'}, {'measure': 'Number of needle pass', 'timeFrame': '30 minute', 'description': 'Needle pass is defined as skin puncture plus number of redirection attempts'}, {'measure': 'The procedure duration time', 'timeFrame': '30 minute', 'description': 'The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow'}, {'measure': 'Time interval to determine needle insertion site', 'timeFrame': '30 minute', 'description': 'Time interval between the operator touches the parturient and the completion of the needle insertion point marking'}, {'measure': 'Time taken for spinal injection', 'timeFrame': '30 minute', 'description': 'The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.'}, {'measure': 'Number of puncture levels', 'timeFrame': '30 minute', 'description': 'Move to a second lumbar space after 3 needle insertion attempts'}, {'measure': 'Patient satisfaction The procedure duration', 'timeFrame': '120 minute', 'description': 'Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.'}, {'measure': 'incidence of complications during puncture', 'timeFrame': '120 minute', 'description': 'Incidence of radicular pain, paresthesia, and blood during spinal needle injection'}, {'measure': 'incidence of postoperative headache', 'timeFrame': '72 hours', 'description': '12-72 hours following spinal anesthesia due to CSF leakage'}, {'measure': 'Incidence of hypotension', 'timeFrame': '2 hours', 'description': 'A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg'}, {'measure': 'Failure rate of spinal anesthesia', 'timeFrame': '120 minute', 'description': 'Number of parturients who need additional analgesic drug or conversion to general anesthesia'}, {'measure': 'dermatome level of sensory block', 'timeFrame': '10 minute', 'description': 'thoracic dermatome level of sensory block assessed by pinprick test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Anesthesia', 'Cesarean Delivery', 'Ultrasound'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section.\n\nThe primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.', 'detailedDescription': 'Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese (BMI ≥ 50 kg/m2) pregnant women.\n\nThe manual palpation technique, preferred in neuraxial anesthesia, may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients.\n\nThis study will be a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups. Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study only includes pregnant patients who will deliver by elective cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturient who will receive selective cesarean delivery under spinal anesthesia\n* ASA 3 scheduled for elective sections\n* BMI≥50 kg/m2\n* Normal singleton pregnancy\n\n * 37 weeks of gestation\n\nExclusion Criteria:\n\n* Multiple gestations\n* Emergency C-section\n* Exist contraindications of spinal anesthesia\n* Local anesthetics allergy\n* BMI\\<50 kg/m2\n* History of lumbar spinal diseases and lumbar surgery\n* Parturient refusal'}, 'identificationModule': {'nctId': 'NCT06410820', 'briefTitle': 'Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI ≥ 50 kg/m2. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11-2022/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound method group', 'description': 'The ultrasound-assisted technique will be used for spinal anesthesia performance.', 'interventionNames': ['Device: Procedure/Surgery: Ultrasound method group']}, {'type': 'EXPERIMENTAL', 'label': 'Landmark method group', 'description': 'Land-mark assisted technique will be used for spinal anesthesia performance.', 'interventionNames': ['Device: Landmark method group']}], 'interventions': [{'name': 'Procedure/Surgery: Ultrasound method group', 'type': 'DEVICE', 'description': 'In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines.\n\nWhen the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.', 'armGroupLabels': ['Ultrasound method group']}, {'name': 'Landmark method group', 'type': 'DEVICE', 'description': 'In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.', 'armGroupLabels': ['Landmark method group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Betul Basaran, MD,DESA', 'role': 'CONTACT', 'email': 'betulbasaran1@yahoo.com', 'phone': '+90 338 226 33 20'}], 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'Betul Basaran, MD,DESA', 'role': 'CONTACT', 'email': 'betulbasaran1@yahoo.com', 'phone': '+903382263000'}], 'overallOfficials': [{'name': 'Ayşegül Bilge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karaman TRH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}