Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-03 @ 7:19 PM
Study NCT ID:
NCT01445756
Status:
COMPLETED
Last Update Posted:
2014-08-26
First Post:
2011-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Lidocaine for Pain Control With Intrauterine Device (IUD) 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'}]}, '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2011-08-23', 'studyFirstSubmitQcDate': '2011-10-03', 'lastUpdatePostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain level from no Lidocaine administered to after Lidocaine is administered', 'timeFrame': 'Pain assessments prior to procedure, immediately after procedure, and 10 minutes after the procedure', 'description': "The investigators plan to engage 40 patients in this study, and will ask each to fill out a questionnaire that covers age, ethnicity, pregnancy history, reason for IUD insertion and recent medication use. Patients will be asked to assess their pain on 3 separate occasions during the visit, by marking an X on a Visual Analog Scale. Providers will also be asked to fill out a questionnaire covering their experience with the interventions as well as their assessment of the patients' pain during the procedures."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intrauterine Device'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.', 'detailedDescription': 'The investigators research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 18 years old\n\nExclusion Criteria:\n\n* Age \\<18\n* Non-English speaking\n* Illiterate\n* History of pregnancy with delivery \\>20 weeks\n* History of prior IUD insertion or attempt'}, 'identificationModule': {'nctId': 'NCT01445756', 'briefTitle': 'Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Topical Lidocaine for Pain Control With IUD Insertion: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-2010-0062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Lidocaine', 'description': 'Topical Lidocaine', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'During the procedure (placement of the IUD), 1ml of gel will be applied to the anterior lip of the cervix. After 1 minute of waiting, a tenaculum will be placed to steady the cervix. The catheter will be introduced into the cervical canal, past the external os and 1-1.5ml of gel will be placed into the canal. After another minute, the IUD will be placed in the standard fashion.', 'armGroupLabels': ['Topical Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['No intervention'], 'description': 'Placebo; no topical lidocaine administered', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "University Health Services Women's Care Clinic", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mary Landry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}