Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-01-22 @ 1:23 PM
Study NCT ID:
NCT02184559
Status:
UNKNOWN
Last Update Posted:
2014-07-09
First Post:
2014-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-08', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-07-08', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption morphinize', 'timeFrame': '48 hours', 'description': 'the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours'}], 'secondaryOutcomes': [{'measure': 'Analgesic efficiency', 'timeFrame': '48 hours', 'description': 'the Score of pain measured by simple numerical rating scales start the first hours one asks for a complementary analgesia to the 48 th hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scheduled Caesarian Section']}, 'descriptionModule': {'briefSummary': 'The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.\n\nThe purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman whose age is 18 years\n* Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia\n* Woman ASA I and II\n* Term = 37 LIMITED COMPANIES\n* Woman primipare or not\n* Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol\n\nExclusion Criteria:\n\n* Minor Woman\n* Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm \\> 38.5 ° C)\n* Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN\n* The surgical histories of laparotomy\n* The morbid obesity BMI \\> 35\n* Dysgravidies\n* Woman not being affiliated to the national insurance scheme\n* Woman under legal protection\n* Woman not having signed an informed consent'}, 'identificationModule': {'nctId': 'NCT02184559', 'briefTitle': 'Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration', 'orgStudyIdInfo': {'id': '2011-005690-23'}, 'secondaryIdInfos': [{'id': '2011-38', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAP block', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'infiltration continues', 'interventionNames': ['Device: The infiltration continues catheter']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section', 'armGroupLabels': ['TAP block']}, {'name': 'The infiltration continues catheter', 'type': 'DEVICE', 'armGroupLabels': ['infiltration continues']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'aurelie BOURGOIN', 'role': 'CONTACT', 'email': 'aurelie.bourgoin@ap-hm.fr'}, {'name': 'aurelie BOURGOIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'aurelie BOURGOIN', 'role': 'CONTACT', 'email': 'aurelie.bourgoin@ap-hm.fr'}], 'overallOfficials': [{'name': 'loic MONDOLONI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}