Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 10:07 PM
Study NCT ID:
NCT02905695
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2016-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-partum Perineal Pain - Chirocaine®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-09-11', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-partum perineal pain measured by a numerical rating scale', 'timeFrame': '8 hours post partum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-partum Perineal pain', 'Episiotomy', 'First-degree tear'], 'conditions': ['Post-partum Perineal Pain', 'Episiotomy', 'Vaginal Tear']}, 'descriptionModule': {'briefSummary': 'The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria:\n* Patients aged 18-45 years\n* Single pregnancy.\n* Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.\n* Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.\n* Patients affiliated to a national insurance scheme\n* Patients who have given their written consent\n\nExclusion Criteria:\n\n* Patient not speaking, reading, writing French.\n* Multiple pregnancy.\n* Breech delivery or instrumental delivery by forceps or spatula.\n* Intact perineum.\n* No epidural analgesia.\n* Patient who represent contraindication to local anesthetics, severe arterial hypotension.\n* Previous tear requiring sutures.'}, 'identificationModule': {'nctId': 'NCT02905695', 'acronym': 'EPISIO', 'briefTitle': 'Post-partum Perineal Pain - Chirocaine®', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear', 'orgStudyIdInfo': {'id': '2010/44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Chirocaine', 'interventionNames': ['Drug: Chirocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Chirocaine', 'type': 'DRUG', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Jean-Marc Ayoubi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}