Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT06832995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine titration', 'timeFrame': 'after surgery, in the post-anesthetic care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Hip', 'Arthropathy of Knee']}, 'descriptionModule': {'briefSummary': 'Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization.\n\nThe association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Each patient who underwent unilateral knee, total knee and total hip arthroplasty at the Sévigné Private Hospital between January 1, 2023, and December 31, 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total hip arthroplasty\n* Total Knee Arthroplasty\n* Uni-compartmental knee arthroplasty (UKA)\n\nExclusion Criteria:\n\n* Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone'}, 'identificationModule': {'nctId': 'NCT06832995', 'acronym': 'PAMTA', 'briefTitle': 'Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Privé Sévigné'}, 'officialTitle': 'Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties: a Single-center Retrospective Study', 'orgStudyIdInfo': {'id': '2024-HPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group T: IV morphine administered during the PACU stay', 'interventionNames': ['Drug: IV morphine administered during the PACU stay']}, {'label': 'group NT: no titration required in PACU'}], 'interventions': [{'name': 'IV morphine administered during the PACU stay', 'type': 'DRUG', 'description': 'IV morphine administered during the PACU stay', 'armGroupLabels': ['group T: IV morphine administered during the PACU stay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35051', 'city': 'Cesson-Sévigné', 'country': 'France', 'facility': 'Hôpital Privé Sévigné', 'geoPoint': {'lat': 48.1212, 'lon': -1.603}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Privé Sévigné', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}