Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT03956303
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test', 'timeFrame': 'Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected.', 'description': 'time to reach T10 sensory block by pinprick test'}, {'measure': 'Spinal Block Quality by questioning', 'timeFrame': 'At the end of surgery', 'description': 'the intensity of spinal block will be evaluated via questioning the surgeon and the patient. the surgeon will grade the abdominal relaxivity as good, medium or poor The patient will evaluate spinal block analgesia quality as good, medium or poor.'}, {'measure': 'Change the sensory block level at intraoperative period by pinprick test', 'timeFrame': 'Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The highest measured level by pinprick test be recorded', 'description': 'the level of maximum sensory block by pinprick test'}, {'measure': 'time to reach maximum level of sensory block at intraoperative period by pinprick test', 'timeFrame': 'Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. the time to reach the highest measured by pinprick test will be recorded.', 'description': 'time to reach maximum level of sensory block by pinprick test'}, {'measure': 'Change over time at the level of sensory block at intraoperative period by pinprick test', 'timeFrame': 'Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The time to two segment regression of maximum sensory block by pinprick test will be recorded.', 'description': 'time to two segment regression of maximum sensory block by pinprick test'}, {'measure': 'Change in motor block level from PACU to discharge', 'timeFrame': 'every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale', 'description': 'motor block recovery time by bromage scale'}, {'measure': 'Change to regression of sensory block by pinprick test', 'timeFrame': 'In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours', 'description': 'time to S2 regression of sensory block by pinprick test'}], 'secondaryOutcomes': [{'measure': 'Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure', 'timeFrame': 'Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. every 30 minutes up to 2 hours', 'description': 'measurement of systolic , diastolic and mean arterial blood pressure'}, {'measure': 'Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone', 'timeFrame': 'on postoperative day 3 by phone.', 'description': 'postoperative complications ( head ache, back pain, numbness of lower extremity )by phone'}, {'measure': 'evaluation of umbilical vein blood gas analysis', 'timeFrame': 'immediately after fetus delivery', 'description': 'umbilical vein blood sample will be obtained immediately after delivery of the fetus and will a blood gas analysis will be performed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia, Spinal', 'Cesarean Section', 'Levobupivacaine'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': "The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.", 'detailedDescription': 'Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens.\n\nGroup 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.\n\nBaby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.\n\nHemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.\n\nThe surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.\n\nThe patient will evaluate spinal block analgesia quality as good, medium or poor.\n\nPain scores are going to be evaluated by VAS at the beginning, uterine incision and during abdominal closure. Time for first analgesic requirement and postoperative pain is also going to be evaluated by VAS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Pregnancy at Term\n* Scheduled for elective caesarean delivery\n\nExclusion Criteria:\n\n* contraindication for spinal anesthesia\n* drug allergy\n* pregnancy related disorders (hypertension, placenta previa, fetal problems)'}, 'identificationModule': {'nctId': 'NCT03956303', 'briefTitle': 'Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.', 'orgStudyIdInfo': {'id': 'osagir2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plain Levobupivacaine (Chirocaine (% 0.5)', 'description': 'Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain', 'interventionNames': ['Drug: Chirocaine %0.5']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine (Chirocaine % 0,75) + dextrose 40', 'description': 'Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40', 'interventionNames': ['Drug: Chirocaine Heavy 40']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine (Chirocaine % 0,75) + dextrose 60', 'description': 'Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60', 'interventionNames': ['Drug: Chirocaine Heavy 60']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine (Chirocaine % 0,75) + dextrose 80', 'description': 'Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80', 'interventionNames': ['Drug: Chirocaine Heavy 80']}], 'interventions': [{'name': 'Chirocaine %0.5', 'type': 'DRUG', 'otherNames': ['Plain levobupivacaine', 'Group 1'], 'description': 'Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl', 'armGroupLabels': ['Plain Levobupivacaine (Chirocaine (% 0.5)']}, {'name': 'Chirocaine Heavy 40', 'type': 'DRUG', 'otherNames': ['levobupivacaine heavy 40', 'Group 2'], 'description': 'Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl', 'armGroupLabels': ['Levobupivacaine (Chirocaine % 0,75) + dextrose 40']}, {'name': 'Chirocaine Heavy 60', 'type': 'DRUG', 'otherNames': ['levobupivacaine heavy 60', 'Group 3'], 'description': 'Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl', 'armGroupLabels': ['Levobupivacaine (Chirocaine % 0,75) + dextrose 60']}, {'name': 'Chirocaine Heavy 80', 'type': 'DRUG', 'otherNames': ['levobupivacaine heavy 80', 'Group 4'], 'description': 'Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl', 'armGroupLabels': ['Levobupivacaine (Chirocaine % 0,75) + dextrose 80']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ozlem Sagir, Assist. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Balikesir University School of Medicine Department of Anesthesia and Reanimation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Ozlem Sagir, MD', 'investigatorAffiliation': 'Balikesir University'}}}}