Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:21 AM
Study NCT ID:
NCT03122756
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2017-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in post-cesarean pain', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'post-cesarean pain degree scored by the patient on Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'sensory recovery', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'sensory recovery time by cold object'}, {'measure': 'motor recovery', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'motor recovery time on Bromage scale'}, {'measure': 'nausea', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'postoperative nausea'}, {'measure': 'vomiting', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'postoperative vomiting'}, {'measure': 'shivering', 'timeFrame': '2, 4, 8 and 12 hours after the procedure', 'description': 'postoperative shivering'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravenous Dexamethasone', 'Spinal Anesthesia', 'Post-cesarean Section Pain'], 'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': '\\*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.', 'detailedDescription': '\\*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.\n\n\\*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Pregnant women who will be planned for elective cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * A gestational age of 38 weeks or more and planned for elective cesarean section.\n * Living fetus.\n * Any number of previous cesarean section.\n * Intact amniotic membranes.\n * No history of bleeding tendency.\n* Exclusion Criteria:\n\n * Refuse to participate after counseling.\n * Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).\n * High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).\n * Contraindication to corticosteroids e.g. systemic fungal infection\n * Steroid medication one week before the operation.\n * Chronic pain or daily intake of analgesic.\n * Abnormal placentation e.g. placenta previa.\n * Intrauterine infection.'}, 'identificationModule': {'nctId': 'NCT03122756', 'briefTitle': 'Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IVD-SA-CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (D)', 'description': 'will include 50 women who will receive intravenous dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group (C)', 'description': 'will include 50 women who will receive intravenous normal saline (0.9 %).', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': 'Intravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia.', 'armGroupLabels': ['Group (D)']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.', 'armGroupLabels': ['Group (C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud AA ElShourbagy, MD', 'role': 'CONTACT', 'email': 'elshourbagym22@hotmail.com', 'phone': '+201001448189'}], 'facility': 'Ain Shams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud AA ElShourbagy, MD', 'role': 'CONTACT', 'email': 'elshourbagym22@hotmail.com', 'phone': '+201001448189'}], 'overallOfficials': [{'name': 'Mahmoud AA ElShourbagy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Obstetrics and Gynecology'}, {'name': 'Dalia A Nasr, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Anesthesia, Intensive Care and Pain'}, {'name': 'Bassem A Islam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer in Obstetrics & Gynecology'}, {'name': 'Abdelhameed AA Ismail, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident of Obstetrics & Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Abdelhameed Ahmed Ali Ismail', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}