Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-04 @ 3:58 PM
Study NCT ID:
NCT03072394
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Anesthesia in Radial Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 444}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2021-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale of Pain Perception during sheath insertion', 'timeFrame': 'During artery puncture', 'description': 'The primary end-point of the study is the perception of radial pain assessed during artery puncture'}, {'measure': 'Visual Analog Scale of Pain Perception after sheath removal', 'timeFrame': '30 minutes after sheath removal', 'description': 'The primary end-point of the study is the perception of radial pain assessed 30 minutes after sheath removal'}], 'secondaryOutcomes': [{'measure': 'Puncture efficiency (number of puncture attempts)', 'timeFrame': 'During radial artery catheterization', 'description': 'The number of puncture attempts, the total time required before successful sheath insertion are documented in each group and constitute the secondary end points of the study.'}, {'measure': 'Radial artery spasm', 'timeFrame': 'During radial artery catheterization', 'description': 'The occurrence of radial artery spasm in each group during radial artery catheterization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Local', 'Coronary Artery Disease', 'Catheter Site Discomfort', 'Catheter Site Pain']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial to test the efficacy of EMLA cream (lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight) in comparison to the established local anesthesia (LA) protocol of lidocaine subcutaneous injection, in providing adequate peri-operative local anesthesia during transradial coronary angiography.', 'detailedDescription': "A total of 444 consecutive patients, who are referred for elective coronary angiography to 1st Cardiology Department cathlab, with the suspicion of coronary artery disease (CAD) will be enrolled in this study. Exclusion criteria are acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal. Baseline clinical, demographic and procedural data of the study population were recorded.\n\nParticipants will be randomly assigned to either the EMLA (AO) or the lidocaine group (LA), by a randomization table.\n\nPrimary end-point: the perception of radial pain assessed during artery puncture and 30 minutes after sheath removal.\n\nSecondary end-point: The number of puncture attempts, the total time required before successful sheath insertion, and the occurrence of radial artery spasm will be also documented in each group\n\nParticipants will be observed for 4 hours post angiography for development of local complications or side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* referral for elective diagnostic coronary angiography\n\nExclusion Criteria:\n\n* acute coronary syndrome, previous ipsilateral transradial approach, Raynaud's syndrome, abnormal renal function with or without need for hemodialysis, known history of sensitivity to local anesthetics, non-palpable radial pulse, abnormal Barbeau's test and patient's refusal."}, 'identificationModule': {'nctId': 'NCT03072394', 'acronym': 'RAOLA', 'briefTitle': 'Local Anesthesia in Radial Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Hippocration General Hospital'}, 'officialTitle': 'Anesthetic Ointment vs Local Injectable Anesthetic in Trans-radial Cardiac Catheterization: The RAOLA Study', 'orgStudyIdInfo': {'id': 'HippocratioGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMLA anesthetic ointment (AO)', 'description': 'In AO group a layer of 2.5 gr EMLA cream (standard adult dose) is applied to both wrists, 1 cm above the styloid process of the radius 30 minutes before the puncture, by an experienced cathlab nurse.', 'interventionNames': ['Drug: Local anesthetic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local Skin Anesthetic Injection (LA)', 'description': 'In LA group the radial artery is infiltrated with 1-2 mL of 2% lidocaine, using a 26 G needle, 0.5-1 cm proximal to the styloid process one minute before the puncture', 'interventionNames': ['Drug: local anaesthetic injection']}], 'interventions': [{'name': 'Local anesthetic', 'type': 'DRUG', 'otherNames': ['Local anesthetic ointment'], 'description': 'Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment', 'armGroupLabels': ['EMLA anesthetic ointment (AO)']}, {'name': 'local anaesthetic injection', 'type': 'DRUG', 'otherNames': ['Skin anethesia by lidocaine injection'], 'description': 'Local skin anesthesia during radial coronary artery catheterization by lidocaine injection', 'armGroupLabels': ['Local Skin Anesthetic Injection (LA)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Dimitris Tousoulis, Ass. Professor', 'role': 'CONTACT', 'email': 'tousouli@med.uoa.gr', 'phone': '+30 210 7782446'}, {'name': 'George Latsios, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hippocration Hospital, Athens University Medical School', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'George Latsios, MD PhD', 'role': 'CONTACT', 'email': 'glatsios@gmail.com'}], 'overallOfficials': [{'name': 'Dimitris Tousoulis, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Cardiology'}, {'name': 'George Latsios, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Cardiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hippocration General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Dimitris Tousoulis', 'investigatorAffiliation': 'Hippocration General Hospital'}}}}