Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01505920
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2012-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-13', 'studyFirstSubmitDate': '2012-01-05', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog pain scores immediately after the excision', 'timeFrame': 'Immediately after the excision'}], 'secondaryOutcomes': [{'measure': 'Visual analog pain scores at the time of anesthetic application', 'timeFrame': 'At the time of anesthetic application'}, {'measure': 'Visual analog pain scores at 30 minutes after the procedure', 'timeFrame': 'At 30 minutes after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '23921860', 'type': 'DERIVED', 'citation': 'Vanichtantikul A, Charoenkwan K. Lidocaine spray compared with submucosal injection for reducing pain during loop electrosurgical excision procedure: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):553-7. doi: 10.1097/AOG.0b013e31829d888e.'}]}, 'descriptionModule': {'briefSummary': 'Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself.\n\nLidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application.\n\nAn objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any degrees of cervical dysplasia detected from cervical cytology or histology\n* Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment\n\nExclusion Criteria:\n\n* Allergy to lidocaine\n* Pregnancy\n* Previous history of cervical operation including conization, LEEP, laser therapy and cryotherapy\n* Cardiac arrhythmia\n* Neural disease with impaired sensation\n* Lower urinary tract cancer\n* Coagulation defect\n* Drug dependence\n* Lower genital tract infection\n* Obvious invasive disease of the cervix'}, 'identificationModule': {'nctId': 'NCT01505920', 'briefTitle': 'Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OBG-11-08-15A-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine spray', 'description': '10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision', 'interventionNames': ['Procedure: Lidocaine spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine submucosal injection', 'description': '2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision', 'interventionNames': ['Procedure: Lidocaine submucosal injection']}], 'interventions': [{'name': 'Lidocaine spray', 'type': 'PROCEDURE', 'description': '10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision', 'armGroupLabels': ['Lidocaine spray']}, {'name': 'Lidocaine submucosal injection', 'type': 'PROCEDURE', 'description': '2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision', 'armGroupLabels': ['Lidocaine submucosal injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of OB-GYN, Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Kittipat Charoenkwan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}, {'name': 'Asama Vanichtantikul, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kittipat Charoenkwan, M.D.', 'investigatorAffiliation': 'Chiang Mai University'}}}}