Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT06056934
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2023-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine sulfate equivalent rate in each group, mg/day', 'timeFrame': 'Pre-operative', 'description': 'mg/day'}, {'measure': 'Morphine sulfate equivalent rate in each group, mg/day', 'timeFrame': 'Early post-operative between Day 0 and Day 3', 'description': 'mg/day'}, {'measure': 'Morphine sulfate equivalent rate in each group, mg/day', 'timeFrame': 'Late post-operative between Day 4 and day 7', 'description': 'mg/day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Deterioration']}, 'descriptionModule': {'briefSummary': 'Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions.\n\nSurgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic.\n\nAdequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them.\n\nPain management is a matter of protocol in the UPOG department of the CHU de Nîmes.\n\nPain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management.\n\nThe investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '76 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 75 years\n* Hospitalized for a fracture of the upper extremity of the femur at the UPOG of the CHU de Nîmes during 2022\n\nExclusion Criteria:\n\n* Opioid allergy\n* No surgical management of fracture\n* Long-term treatment with high-dose opiates\n* Patient has objected to the use of his or her data.'}, 'identificationModule': {'nctId': 'NCT06056934', 'acronym': 'ALGOGER', 'briefTitle': 'Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Retrospective Study of Protocol-based Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized at UPOG for Fracture of the Upper Extremity of the Femur in 2022', 'orgStudyIdInfo': {'id': 'Local/2023'}}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'CHU de Nîmes', 'country': 'France', 'facility': 'GAULTIER', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}