Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
Study NCT ID:
NCT02086292
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2014-03-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016602', 'term': 'Needlestick Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014951', 'term': 'Wounds, Stab'}, {'id': 'D014950', 'term': 'Wounds, Penetrating'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '60 seconds', 'description': '1. visual analog scale 0-100mm\n2. questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Injections', 'Lidocaine', 'Pain', 'Healthy volunteers'], 'conditions': ['Needlestick Injuries']}, 'referencesModule': {'references': [{'pmid': '27595956', 'type': 'RESULT', 'citation': 'Ballo S, Hjelseng T, Tangen LF, Lundbom JS, Skarsvag T, Finsen V. The Influence of Injected Volume on Discomfort During Administration of Digital Block. J Hand Surg Asian Pac Vol. 2016 Oct;21(3):369-73. doi: 10.1142/S2424835516500363.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.', 'detailedDescription': 'Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 - 65\n\nExclusion Criteria:\n\n* regular use of analgesics\n* known hypersensitivity of local anaesthetic\n* renal-, heart- or liver disease\n* known peripheral neuropathy or diabetes mellitus\n* local infection on injection site\n* circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)'}, 'identificationModule': {'nctId': 'NCT02086292', 'briefTitle': 'The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic', 'orgStudyIdInfo': {'id': '2013/2297D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 milliliter lidocaine', 'description': '2 ml 1% Lidocaine in one ring finger, 1 ml 2% Lidocaine in the other ring finger', 'interventionNames': ['Procedure: 2 ml 1% Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': '1 milliliter lidocaine', 'description': '1 ml 1% Lidocaine in one ring finger, 2 ml 2% Lidocaine in the other ring finger', 'interventionNames': ['Procedure: 1 ml 2% Lidocaine']}], 'interventions': [{'name': '2 ml 1% Lidocaine', 'type': 'PROCEDURE', 'armGroupLabels': ['2 milliliter lidocaine']}, {'name': '1 ml 2% Lidocaine', 'type': 'PROCEDURE', 'armGroupLabels': ['1 milliliter lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of neuroscience, NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Vilhjalmur Finsen, prof md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}