Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER" (ALGOGER)

September 25, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • CHU De Nîmes
      • Nîmes, CHU De Nîmes, France, 30029
        • Recruiting
        • GAULTIER
        • Contact:
        • Principal Investigator:
          • GERONIMI-ROBELIN
        • Sub-Investigator:
          • GAULTIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Pre-operative
mg/day
Pre-operative
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Early post-operative between Day 0 and Day 3
mg/day
Early post-operative between Day 0 and Day 3
Morphine sulfate equivalent rate in each group, mg/day
Time Frame: Late post-operative between Day 4 and day 7
mg/day
Late post-operative between Day 4 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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