Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04379102
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application
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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'C028388', 'term': 'thymus-leukemia antigens'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The VAS scores of patients after the application of IUDs', 'timeFrame': '1 month', 'description': 'The VAS scores of patients in both groups reported one month after the application of IUDs (Patients mark their pain intensity from 1 to 10 in vas scoring. In scoring, 1 point is the lowest score and shows that the patient has low pain, 10 is the highest score and shows severe pain.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUD', 'Contraception', 'Pain']}, 'descriptionModule': {'briefSummary': "Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the L4-S4 dermatomes as quaddles."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with underlying chronic diseases which could cause chronic pelvic pain such as endometriosis and which makes them prone to infections such as diabetes mellitus were excluded from the study. Furthermore, women by whom a complication had arised during the IUD insertion, such as uterine perforation, were also excluded from the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not pregnant women\n* healty women age between 18- 45 years old\n\nExclusion Criteria:\n\n* chronic diseases which could cause chronic pelvic pain such as endometriosis\n* which makes them prone to infections such as diabetes mellitus\n* complication had arised during the IUD insertion, such as uterine perforation'}, 'identificationModule': {'nctId': 'NCT04379102', 'briefTitle': 'The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Role Of Local Anesthetics Effects During Intrauterine Device Application', 'orgStudyIdInfo': {'id': 'ntria'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IUD patients', 'description': '80 patients who matched the inclusion criteria and received IUDs', 'interventionNames': ['Other: with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )']}], 'interventions': [{'name': 'with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )', 'type': 'OTHER', 'otherNames': ['without NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )'], 'description': "Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations.", 'armGroupLabels': ['IUD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pinar Yalcin Bahat', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pınar Yalcin bahat', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}