Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02549105
Status:
UNKNOWN
Last Update Posted:
2015-09-15
First Post:
2015-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TIME TO THE FIRST DOSE OF RESCUE ANALGESIC IN THE FIRST 6 HOURS', 'timeFrame': '6 H'}], 'secondaryOutcomes': [{'measure': 'POSTOPERATIVE PAIN ACCORDING TO VAS', 'timeFrame': '24 H'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EMLA CREAM', 'LIDOCAINE INFILTERATION', 'PAIN RELIEF'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And wound Infiltration with Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial.', 'detailedDescription': 'The purpose of this study is to compare the effectiveness of topically applied lidocaine-prilocaine (EMLA) cream with local anesthetic (lidocaine) infiltration on post-cesarean section pain.\n\nResearch Question:\n\nIs lidocaine-prilocaine (EMLA) cream application effective as compared to local anesthetic (lidocaine) infiltration on post-caesarean section pain?\n\nResearch Hypothesis:\n\nLidocaine-prilocaine (EMLA) cream application is effective in post\\_caesarean section pain as compared to local anesthetic (lidocaine) infiltration.\n\nClinical Application :\n\nTopical Lidocaine-prilocaine (EMLA) cream could be applied frequent times postoperatively, unlike infiltration with local anesthetic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 40 years.\n2. Patient American Society of Anesthesiologists physical status І or П.\n3. Gestational age of pregnancy of 37w or more.\n4. Patient have no previous section or have 1or 2 previous sections.\n5. Patient having no medical disorders.\n6. Patient with no obstetrical complications.\n\nExclusion Criteria:\n\n1. age below18 or above 40.\n2. Women American Society of Anesthesiologists physical status ш or more.\n3. Women having more than 2 previous cesarean section.\n4. Women receive cardio vascular drugs or having history of cardio vascular disease.\n5. Women with Medical disorders with pregnancy as diabetes milletus.\n6. Women having obstetrical complications as antepartum hemorrhage, pre-eclampsia or eclampsia.\n7. Women having metabolic, hormonal, respiratory, renal and hepatic disease.\n8. Women with any severe allergic condition or severe asthma.\n9. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.'}, 'identificationModule': {'nctId': 'NCT02549105', 'briefTitle': 'Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'A Comparison Between Lidocaine-Prilocaine Cream (EMLA) Application And Wound Infiltration With Lidocaine For Post Caesarean Section Pain Relief : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Ain Shams MH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EMLA CREAM', 'description': 'EMLA CREAM 5 mg TOPICAL APPLICATION FOR CS WOUND AND ASSESSMENT FOR POST OPERATIVE PAIN IN FIRST 6 HOURS', 'interventionNames': ['Drug: EMLA CREAM 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LIDOCAINE INFILTERATION', 'description': 'LIDOCAINE 1 % 20 ml INFILTERATION FOR WOUND AND ASSESSMENT OF POST OPERATIVE PAIN IN FIRST 6 HOURS', 'interventionNames': ['Drug: LIDOCAINE 1 %']}], 'interventions': [{'name': 'EMLA CREAM 5 mg', 'type': 'DRUG', 'otherNames': ['EMLA CREAM, PRILOCAIN 25 LIDOCAIN 25'], 'description': 'EMLA CREAM APPLICATION FOR WOUND AFTER CS', 'armGroupLabels': ['EMLA CREAM']}, {'name': 'LIDOCAINE 1 %', 'type': 'DRUG', 'otherNames': ['XYLOCAINE'], 'description': 'LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS', 'armGroupLabels': ['LIDOCAINE INFILTERATION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11821', 'city': 'Cairo', 'state': 'Abbasya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maged R Aboseda, professor', 'role': 'CONTACT', 'email': 'ahmadhassan376@gmail.com', 'phone': '00201069190707'}], 'facility': 'Ain Shams university Maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'HANY A IBRAHIM, MBBCH', 'role': 'CONTACT', 'email': 'DR.HANY_AYAD@YAHOO.COM', 'phone': '01220034468'}, {'name': 'AHMED M MAMDOUH, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'MAGED R ABO SAEDA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIN SHAMS MATERNAL HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RESIDENT DOCTOR', 'investigatorFullName': 'HANY AYAD IBRAHIM', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}