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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056934
Other study ID # Local/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2023
Est. completion date October 30, 2023

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Nimes
Contact GAULTIER
Phone O6.05.16.89.71
Email josephine.gaultier@free.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. Surgery 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. Adequate 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. Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes. Pain 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. The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date October 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 76 Years and older
Eligibility Inclusion Criteria: - Patients aged > 75 years - Hospitalized for a fracture of the upper extremity of the femur at the UPOG of the CHU de Nîmes during 2022 Exclusion Criteria: - Opioid allergy - No surgical management of fracture - Long-term treatment with high-dose opiates - Patient has objected to the use of his or her data.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France GAULTIER Nîmes CHU De Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine sulfate equivalent rate in each group, mg/day mg/day Pre-operative
Primary Morphine sulfate equivalent rate in each group, mg/day mg/day Early post-operative between Day 0 and Day 3
Primary Morphine sulfate equivalent rate in each group, mg/day mg/day Late post-operative between Day 4 and day 7
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