Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT04397406
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2020-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients.\n\nGroup C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of maternal analgesia', 'timeFrame': '24 hours after epidural injection', 'description': 'Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4.\n\nThe pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, \\> 7: severe pain).'}], 'secondaryOutcomes': [{'measure': 'Onset of maternal analgesia.', 'timeFrame': 'One hour after epidural injection', 'description': 'The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) \\<3.'}, {'measure': 'Complications of drugs of epidural technique', 'timeFrame': '24 hours after epidural injection', 'description': 'Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epidural Analgesia', 'Painless Labor', 'Dexmedetomidine', 'Fentanyl', 'Levobupivacaine']}, 'descriptionModule': {'briefSummary': 'Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.\n\nThe aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status class II and III,\n* Full term pregnancy.\n\nExclusion Criteria:\n\n* Patient refusal to epidural analgesia,\n* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),\n* Cardiac diseases\n* Severe pre-eclampsia,\n* Breech presentations\n* Antepartum hemorrhage\n* Cephalopelvic disproportion\n* Body mass index ≥40 kg/m2.'}, 'identificationModule': {'nctId': 'NCT04397406', 'briefTitle': 'Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': '33447/10/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (Control group)', 'description': 'pidural analgesia with levobupivacaine alone', 'interventionNames': ['Drug: levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D (Dexmedetomidine group)', 'description': 'Epidural analgesia with levobupivacaine and dexmedetomidine', 'interventionNames': ['Drug: levobupivacaine', 'Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Group F (Fentanyl group)', 'description': 'Epidural analgesia with levobupivacaine and fentanyl', 'interventionNames': ['Drug: levobupivacaine', 'Drug: Fentanyl']}], 'interventions': [{'name': 'levobupivacaine', 'type': 'DRUG', 'description': 'The patients will receive 15 ml of 0.125% levobupivacaine.', 'armGroupLabels': ['Group C (Control group)', 'Group D (Dexmedetomidine group)', 'Group F (Fentanyl group)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.', 'armGroupLabels': ['Group D (Dexmedetomidine group)']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.', 'armGroupLabels': ['Group F (Fentanyl group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Hend Mahmoud Moneeb El-shazly', 'investigatorAffiliation': 'Tanta University'}}}}