Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT03075358
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspiration pain', 'timeFrame': 'Immediately following endometrial aspiration biopsy', 'description': 'A visual analog scale pain score associated with endometrial aspiration biopsy'}, {'measure': 'Postprocedure pain', 'timeFrame': '10 minute after procedure completion', 'description': 'A visual analog scale pain score after the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Bleeding']}, 'descriptionModule': {'briefSummary': 'Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.\n\nThe aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital\n\nExclusion Criteria:\n\n* Lidocaine allergy\n* Pregnancy\n* Previous uterine or cervical surgical procedures\n* Neurological abnormalities\n* Coagulopathy\n* Infection of cervix, vagina, or pelvic cavity\n* Taking any analgesic drugs within 4 hours before the procedure'}, 'identificationModule': {'nctId': 'NCT03075358', 'briefTitle': 'Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OBG-2559-04137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine spray', 'interventionNames': ['Drug: Lidocaine spray']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normal saline spray', 'interventionNames': ['Other: Normal saline spray']}, {'type': 'NO_INTERVENTION', 'label': 'No spray'}], 'interventions': [{'name': 'Lidocaine spray', 'type': 'DRUG', 'description': 'Patients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure.', 'armGroupLabels': ['Lidocaine spray']}, {'name': 'Normal saline spray', 'type': 'OTHER', 'description': '0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure', 'armGroupLabels': ['Normal saline spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of OB-GYN, Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Kittipat Charoenkwan, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Chiang Mai University'}, {'name': 'Ratpaporn Piyawetchakarn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kittipat Charoenkwan, MD', 'investigatorAffiliation': 'Chiang Mai University'}}}}