Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-16 @ 10:11 AM
Study NCT ID:
NCT02039661
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2014-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': '3 months', 'description': 'Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was performed at 3 different time points: immediately before to the procedure, during the procedure (immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients were asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Curettage;', 'Pain Score'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The effect of lidocaine spray on pain relief during endometrial sampling.', 'detailedDescription': "The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.\n\nWe will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years no allergy Patients with abnormal uterine bleeding\n\nExclusion Criteria:\n\n* cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea'}, 'identificationModule': {'nctId': 'NCT02039661', 'briefTitle': 'Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'orgStudyIdInfo': {'id': 'Gookhan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Spray', 'interventionNames': ['Drug: Lidocaine Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'These patients received placebo spray.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine Spray', 'type': 'DRUG', 'description': 'These patients received 2 puff lidocaine spray', 'armGroupLabels': ['Lidocaine Spray']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38210', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Education and Research Hospital of Medicine', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Gökhan Açmaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri Education and Research Hospital of Medicine'}]}, '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'}}}}