FrailtyNCT05445700
The Effects of Frailty on Opioid Consumption
A study of Frailty and Opioid Use, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Opioid Use, Knee Arthropathy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Sep 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients who will undergo unilateral, primary total knee arthroplasty
- Patients who will be operated with spinal anesthesia
Who cannot join
- Patients with ASA IV and above physical status
- Uncooperative patients
- Patients who do not speak Turkish
- Patients on routine opioid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Medical Faculty Hospital
Konya, 42090
About this study
Official title: The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty
The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Demographic data and intraoperative data of the patients will be recorded. Patients will be transferred to the post-operational post-operative care unit (PACU) and patient-controlled analgesia (PCA) will be applied to each patient with a standard protocol. In the postoperative period, the need for analgesics will be recorded for 24 hours, and if additional analgesics are needed, they will be recorded. Pain scores of the patients will be evaluated for 24 hours.
- Conditions
- Frailty, Opioid Use, Knee Arthropathy
- Being tested
- Patient-controlled analgesia pump (PCA)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled analgesia pump (PCA)Device
Each patient will receive a PCA pump with intravenous (i.v.) morphine.
| Study group | Role | What they receive |
|---|---|---|
| Non-frail | Active comparator | FRAIL scale= 0 Receives: Device: Patient-controlled analgesia pump (PCA) |
| Pre_frail | Active comparator | FRAIL scale= 1-2 Receives: Device: Patient-controlled analgesia pump (PCA) |
| Frail | Active comparator | FRAIL scale >2 Receives: Device: Patient-controlled analgesia pump (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total opioid consumption (24 hours)
Measured: Postoperative 24th hour
Secondary outcomes (2)
Visual analog pain scores (VAS)
VAS scores will evaluate at rest and during 45° active knee flexion
Measured: 6,12 and 24 hours
Nausea and vomiting questionnaire
Postoperative nausea and vomiting will be evaluated by asking the patient whether she/he has had nausea and vomiting for 24 hours.
Measured: Postoperative for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jul 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Groups will be determined according to frailty status.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet SARGIN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445700
- Sponsor's protocol ID
- 2022-1
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05445700
- Acronym / sponsor ID
- 2022-1
- Conditions
- Frailty, Opioid Use, Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 6 Jul 2022 (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.
The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Demographic data and intraoperative data of the patients will be recorded. Patients will be transferred to the post-operational post-operative care unit (PACU) and patient-controlled analgesia (PCA) will be applied to each patient with a standard protocol. In the postoperative period, the need for analgesics will be recorded for 24 hours, and if additional analgesics are needed, they will be recorded. Pain scores of the patients will be evaluated for 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Groups will be determined according to frailty status.
| Arm | Type | Receives |
|---|---|---|
| Non-frail | Active comparator | Device: Patient-controlled analgesia pump (PCA)FRAIL scale= 0 |
| Pre_frail | Active comparator | Device: Patient-controlled analgesia pump (PCA)FRAIL scale= 1-2 |
| Frail | Active comparator | Device: Patient-controlled analgesia pump (PCA)FRAIL scale >2 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patients who will undergo unilateral, primary total knee arthroplasty
- Patients who will be operated with spinal anesthesia
Key exclusion criteria (4 listed)
- Patients with ASA IV and above physical status
- Uncooperative patients
- Patients who do not speak Turkish
- Patients on routine opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-controlled analgesia pump (PCA)Each patient will receive a PCA pump with intravenous (i.v.) morphine. | Device | Frail, Non-frail, Pre_frail |
Primary outcome
Opioid consumption
Time frame: Postoperative 24th hour
Total opioid consumption (24 hours)
2 secondary outcomes
Visual analog pain scores (VAS)
Time frame: 6,12 and 24 hours
Nausea and vomiting questionnaire
Time frame: Postoperative for 24 hours
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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?
A study of Frailty and Opioid Use, run by Selcuk University at 1 site in Turkey (Türkiye).
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 27 Dec 2024. 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 Turkey (Türkiye). 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?
Opioid consumption (time frame: Postoperative 24th hour). 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 27 Dec 2024.