Cognitive DeteriorationALGOGERNCT06056934
Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"
An observational study of Cognitive Deterioration, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Cognitive Deterioration
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Cognitive Deterioration
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine sulfate equivalent rate in each group, mg/day
mg/day
Measured: Pre-operative
Morphine sulfate equivalent rate in each group, mg/day
mg/day
Measured: Early post-operative between Day 0 and Day 3
Morphine sulfate equivalent rate in each group, mg/day
mg/day
Measured: Late post-operative between Day 4 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Mar 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeteriorationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056934
- Sponsor's protocol ID
- Local/2023
- Acronym
- ALGOGER
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06056934
- Acronym / sponsor ID
- ALGOGER / Local/2023
- Conditions
- Cognitive Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morphine sulfate equivalent rate in each group, mg/day
Time frame: Pre-operative
mg/day
Morphine sulfate equivalent rate in each group, mg/day
Time frame: Early post-operative between Day 0 and Day 3
mg/day
Morphine sulfate equivalent rate in each group, mg/day
Time frame: Late post-operative between Day 4 and day 7
mg/day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deterioration, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine sulfate equivalent rate in each group, mg/day (time frame: Pre-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.