Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-04-14 @ 2:07 PM
Study NCT ID:
NCT02020551
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2013-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '3 months', 'description': '10 cm VAS scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scores During IUD insertion.'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25759418', 'type': 'DERIVED', 'citation': 'Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\>18 Not pregnant Smear negative\n\nExclusion Criteria:\n\nChronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis'}, 'identificationModule': {'nctId': 'NCT02020551', 'briefTitle': 'Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'orgStudyIdInfo': {'id': 'kerhGA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline spray application', 'description': 'Placebo group', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'lidocaine spray application', 'description': '2 puff lidocaine spray applicated before IUD insertion', 'interventionNames': ['Drug: Lidocaine Spray']}], 'interventions': [{'name': 'Lidocaine Spray', 'type': 'DRUG', 'armGroupLabels': ['lidocaine spray application']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['saline spray application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380210', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Education and Research Hospital of Medicine', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gökhan Açmaz', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}