Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 12:40 AM
Study NCT ID:
NCT05969457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain after surgery', 'timeFrame': '4hours after surgery', 'description': 'Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -\\> 10 correspoding to the worst pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hysterotomy; Affecting Fetus']}, 'descriptionModule': {'briefSummary': 'The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia.\n\nThis injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac.\n\nRandomization takes place before surgery by vNOTES:\n\n* Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) and general anesthesia\n* Control group: Injection of 20mL of placebo (saline) and general anesthesia\n\nIn both groups, systematic intraoperative and postoperative analgesia will be identical.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 to 70 inclusive\n* Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).\n* Person having read and understood the information letter and signed the consent form\n* Person affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Suspicion of malignant pathology\n* History of rectal surgery\n* History of pelvic inflammatory disease\n* Suspicion of recto-vaginal endometriosis\n* Virginity\n* Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule\n* Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection\n* Patients on a low-salt diet\n* History of more than 2 caesarean sections\n* Estimated uterine size \\> 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3\n* BMI \\> 35\n* Contraindication to analgesic molecules in intraoperative and postoperative protocols.'}, 'identificationModule': {'nctId': 'NCT05969457', 'acronym': 'ANOTES', 'briefTitle': 'Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study', 'orgStudyIdInfo': {'id': 'CHU de Rouen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experienced group', 'description': 'Administration of Naropeine', 'interventionNames': ['Drug: Naropeine', 'Other: questionnaires']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Administration of a saline solution', 'interventionNames': ['Other: questionnaires', 'Other: Placebo']}], 'interventions': [{'name': 'Naropeine', 'type': 'DRUG', 'description': 'Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg)', 'armGroupLabels': ['Experienced group']}, {'name': 'questionnaires', 'type': 'OTHER', 'description': 'Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4', 'armGroupLabels': ['Control group', 'Experienced group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Injection of 20 mL of NaCl', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Mallet', 'role': 'CONTACT', 'email': 'secretariat.DRC@chu-rouen.fr', 'phone': '02 32 88 82 65', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe Hospitalier du Havre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}