Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05998551
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Shot Intrathecal Analgesia in Vaginal Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Computer generated number lists and use of sealed opaque envelopes , double blinded trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of pain relief', 'timeFrame': 'Up to 6 hours after intrathecal injection', 'description': 'The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4'}, {'measure': 'analgesic onset time', 'timeFrame': 'within 15 minutes after intrathecal injection', 'description': 'The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4'}, {'measure': 'maximum level of sensory block', 'timeFrame': '15 min after the intrathecal injection', 'description': 'Temperature will be assessed using methylated soaked swabs on both sides of the body'}, {'measure': 'visual analogue scale (VAS) of the labour pain', 'timeFrame': '6 hours after intrathecal injection', 'description': 'The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours'}, {'measure': 'S1 regression time', 'timeFrame': '6 hours after intrathecal injection', 'description': 'S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome'}], 'secondaryOutcomes': [{'measure': 'Maternal blood pressure', 'timeFrame': '6 hours post operative', 'description': 'any change more than 20% of baseline mean arterial pressure'}, {'measure': 'Maternal heart rate', 'timeFrame': '6 hours post operative', 'description': 'any change more than 20% of baseline heart rate'}, {'measure': 'Post operative nausea and vomiting', 'timeFrame': '6 hours post operative', 'description': 'Number of participants having post operative nausea and vomiting'}, {'measure': 'Post operative urinary retention', 'timeFrame': '6 hours post operative', 'description': 'Number of participants having post operative urinary retention'}, {'measure': 'Fetal heart sounds', 'timeFrame': 'from intrathecal injection till delivery', 'description': 'Change more than 20% of fetal heart sounds before delivery'}, {'measure': 'Fetal APGAR score', 'timeFrame': 'till 5 minutes after delivery', 'description': 'APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery']}, 'descriptionModule': {'briefSummary': 'Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery', 'detailedDescription': "Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.\n\nIn this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria:\n\n * Multiparous women who received antenatal care, presented for vaginal delivery of uncomplicated term pregnancy of singleton fetus with engaged fetal head and cervical dilatation of at least 5 cm requiring oxytocin augmentation, and requested analgesia.\n * Age: patients between 22-45 years old.\n* Exclusion criteria:\n\n * Refusal of procedure or participation in the study.\n * Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal abnormalities.\n * Contraindication to neuraxial block.\n * Allergy to any of the study drugs.'}, 'identificationModule': {'nctId': 'NCT05998551', 'briefTitle': 'Single Shot Intrathecal Analgesia in Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.', 'orgStudyIdInfo': {'id': 'intra-thecal analgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine Group', 'description': 'participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl group', 'description': 'participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline', 'interventionNames': ['Drug: Bupivacaine Hcl 0.5% Inj']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine', 'armGroupLabels': ['Dexmedetomidine Group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'intrathecal injection of fentanyl added to hyperbaric bupivacaine', 'armGroupLabels': ['Fentanyl group']}, {'name': 'Bupivacaine Hcl 0.5% Inj', 'type': 'DRUG', 'description': 'intrathecal injection of hyperbaric bupivacaine only', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ainshams university', 'role': 'CONTACT'}], 'facility': 'Ainshams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Nagdy Rashad', 'role': 'CONTACT', 'email': 'mohamed.nagdy@med.asu.edu.eg', 'phone': '01095825826'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}