Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT03747692
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracervical Anasthesia in Outpatient Hystroscopy, Can Procedure be Completed Diagnostic and Therapeutic With no Need to General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'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': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'group 1 will be subjected to intracervical injection of mepicaine hydrochloride 3%iof a local anasthetic as Carbocaine3% and group 2 will be subjected to intracervical injection of 5 ml of normal saline'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups will be used , 1st study group using intracervical anasthesia of a local anasthetic as Carbocaine3%,and 2nd group using NSAIDs and intracervical injection of a placebo ( saline ).Ask the patient to tell about any sense of nausea or vomiting or drowsiness.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-11-18', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tolerated hystroscopy', 'timeFrame': '30 minutes', 'description': 'complete hystroscopy procedure with tolerable degree of pain.'}], 'secondaryOutcomes': [{'measure': 'occurrence of complication', 'timeFrame': '30 minutes', 'description': 'symptoms of vasovagal as vomiting , sweeting and bradycardia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracervical anasthesia , outpatient hystroscopy ,'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'Single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, AUB and missed IUD were assigned for our study. Both Sample size and randomization were done by a computer program. Patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. The control group received NSAI injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. Hystroscopy was done if an abnormality is detected an intervention was done. A descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).', 'detailedDescription': 'Procedures:\n\nAll patients were subjected to:\n\n1. History taking\n2. Verbal consent to participate in our study\n3. Patient put in lithotomy position\n4. Casco speculum was applied exposing the cervix\n5. Betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection\n6. Multiple toothed volselum was used just to fix cervix\n7. 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe\n8. Do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions\n9. Instruments are removed and at least 5 minutes later procedure started.\n10. Hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity\n11. Patient was monitored for pain all through the procedure by descriptive scale, mild, moderate and severe. ( moderate who needed to take rest then continue , severe that necessitated interruption of the procedure\n12. All patients were monitored for signs of vaso vagal attack as sings (low blood pressure and bradycardia) before and if needed during. Occurrence of symptoms as pallor , sweet and fainting\n13. All patients were monitored post procedure for persistence of colicky pain'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. must be under 40 years\n2. must be no history of renal or hepatic disease\n3. must be no known hypersensitivity to local anaesthetic agents\n4. must be no significant vaginal or cervical infection.\n\nExclusion Criteria:\n\n* All patients with history of sever vasovagal attack during any gynecological procedures.'}, 'identificationModule': {'nctId': 'NCT03747692', 'briefTitle': 'Intracervical Anasthesia in Outpatient Hystroscopy, Can Procedure be Completed Diagnostic and Therapeutic With no Need to General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Cairo University Faculty of Medicine', 'orgStudyIdInfo': {'id': 'i18002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'patient put in dorsal postion , insertion of a speculum , sterilization of the cervix then intracervical injection of 5 ml mepicaine hydrochloride a local anasthetic as Carbocaine3%54 mg at site 3 and 9 using a 10 cm syringe', 'interventionNames': ['Procedure: study group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'patient receives one tablet of NSAIDs (diclofenac sodium 50 mg )15 minutes before procedure then 5 ml of normal saline will be injected intracervical using 10 cm syringe then wait for 5 minutes before the procedure', 'interventionNames': ['Procedure: control group']}], 'interventions': [{'name': 'study group', 'type': 'PROCEDURE', 'description': 'local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.', 'armGroupLabels': ['study group']}, {'name': 'control group', 'type': 'PROCEDURE', 'description': 'each patient receives one tablet of NSAIDs (diclofenac sodium 50 mg) and 5ml of a placebo in form of normal saline are injected intracervical 5 minutes before the procedure using 10 mm syringe.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12521', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Outpatient Hystroscopy of Kasr El Ainy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor in cairo univerity', 'investigatorFullName': 'Olfat Nooh Riad Ali', 'investigatorAffiliation': 'Cairo University'}}}}