Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-04 @ 3:53 PM
Study NCT ID:
NCT02155166
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS
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': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-17', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'immediately after LNG-IUS insertion (approx 1 sec)', 'description': 'Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale)'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '2 and 6 hours after the LNG-IUS insertion', 'description': 'To evaluate the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS placement (by by visual analogue scale and face scale)'}, {'measure': 'Discomfort', 'timeFrame': 'immediately after LNG-IUS insertion (approx 1 sec)', 'description': 'To evaluate the level of discomfort associated with the LNG-IUS insertion (By the experience of the patient in terms of LNG-IUS as slightly uncomfortable, uncomfortable, or very uncomfortable)'}, {'measure': 'ease of insertion', 'timeFrame': 'immediately after LNG-IUS insertion (approx 1 sec)', 'description': 'To evaluated the ease of insertion of the LNG-IUS (as rated by the provider)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levonorgestrel-releasing intrauterine system', 'anesthesia', 'pain', 'nulliparous'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25240012', 'type': 'RESULT', 'citation': 'Castro TV, Franceschini SA, Poli-Neto O, Ferriani RA, Silva de Sa MF, Vieira CS. Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel-releasing intrauterine system in women without previous vaginal delivery: a RCT. Hum Reprod. 2014 Nov;29(11):2439-45. doi: 10.1093/humrep/deu233. Epub 2014 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery.\n\nH0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments', 'detailedDescription': 'Objective: To evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery. As secondary objectives, the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS insertion, the level of discomfort associated with the insertion procedure and the ease of insertion of the LNG-IUS will be evaluated.\n\nDesign: open randomized controlled trial Setting: Outpatient contraceptive services Patients: 100 women who want to use the LNG-IUS Interventions: 100 women will be randomized into two groups: a) use of a NSAID (ibuprofen, 400 mg) 1 hour before the LNG-IUS insertion; and b) 2% lidocaine intracervical injection. These women will be evaluated immediately after the LNG-IUS insertion, and then 2 hours and 6 hours after it.\n\nMain outcome measures: Two pain scales will be used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort from the procedure (as rated by the patient). Multivariate logistic regression will be performed to analyze the predictors associated with moderate/severe pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who wanted to use the LNG-IUS as a contraceptive\n* age between 18 and 45 years\n* nulliparity\n* absence of previous vaginal delivery\n\nExclusion Criteria:\n\n* women in categories 3 and/or 4 for LNG-IUS use according to the medical eligibility criteria of the World Health Organization\n* illicit drug and/or alcohol users\n* women with allergies or contraindications to NSAIDs or lidocaine\n* chronic pelvic pain of any etiology\n* abnormalities in the cervix (such as fibrosis or isthmus-cervical incompetence)\n* previous abortion with or without uterine curettage\n* psychiatric disorders\n* continued use of medications that could interfere with the pain threshold'}, 'identificationModule': {'nctId': 'NCT02155166', 'briefTitle': 'Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Injectable Intracervical Anesthesia on the Pain Associated With the Insertion of the Levonorgestrel-releasing Intrauterine System in Women Without Previous Vaginal Delivery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LNG-IUS-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intracervical anesthesia', 'description': 'Intracervical anesthesia with lidocaine 2%', 'interventionNames': ['Drug: Intracervical anesthesia with lidocaine 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ibuprofen', 'description': 'ibuprofen 400 mg', 'interventionNames': ['Drug: ibuprofen 400 mg']}], 'interventions': [{'name': 'Intracervical anesthesia with lidocaine 2%', 'type': 'DRUG', 'description': '5 min before LNG-IUS placemen', 'armGroupLabels': ['intracervical anesthesia']}, {'name': 'ibuprofen 400 mg', 'type': 'DRUG', 'description': '1 hour prior to the LNG-IUS insertion', 'armGroupLabels': ['ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'CAROLINA S VIEIRA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, PhD', 'investigatorFullName': 'Carolina Sales Vieira', 'investigatorAffiliation': 'University of Sao Paulo'}}}}