Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-29 @ 9:33 AM
Study NCT ID:
NCT05250492
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2022-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morphine consumption in the postoperative care unit', 'timeFrame': '1 hour', 'description': 'Postoperative morphine consumption (in mg) in the postoperative care unit'}], 'secondaryOutcomes': [{'measure': 'Postoperative morphine équivalent consumption at postoperative day 1', 'timeFrame': '1 day', 'description': 'postoperative morphine équivalent consumption (in mg) at postoperative day 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Prosthesis', 'Analgesia', 'PENG Block']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, over 18 years old.\n* Patient scheduled for anterior hip prosthesis.\n* Affiliated patient or beneficiary of a social security scheme.\n* Patient having been informed and having signed a free and informed consent.\n\nExclusion Criteria:\n\n* Patient with a contraindication to local anesthesia.\n* Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).\n* Patient participating in another clinical study.\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.\n* Pregnant, breastfeeding or parturient woman.\n* Patient hospitalized without consent.'}, 'identificationModule': {'nctId': 'NCT05250492', 'acronym': 'API', 'briefTitle': 'Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery', 'orgStudyIdInfo': {'id': '2021-A00539-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with PENG block', 'interventionNames': ['Procedure: Prosthetic hip surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with intra-articular infiltration', 'interventionNames': ['Procedure: Prosthetic hip surgery']}], 'interventions': [{'name': 'Prosthetic hip surgery', 'type': 'PROCEDURE', 'description': 'Total hip prosthesis performed by an anterior approach with intra-articular infiltration of an anesthetic product intraoperatively.\n\nOR\n\n\\- Total hip prosthesis performed by an anterior approach with infiltration of the same anesthetic product by ultrasound-guided PENG block intraoperatively.', 'armGroupLabels': ['Patients with PENG block', 'Patients with intra-articular infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56600', 'city': 'Lanester', 'country': 'France', 'facility': 'Jean-François Oudet', 'geoPoint': {'lat': 47.76316, 'lon': -3.3393}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}