The Effects of Frailty on Opioid Consumption

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty

Conditions
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Frailty, Opioid Use, Knee Arthropathy

Intervention / Treatment
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* Device: Patient-controlled analgesia pump (PCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who will undergo unilateral, primary total knee arthroplasty Patients who will be operated with spinal anesthesia Exclusion Criteria: Patients with ASA IV and above physical status Uncooperative patients Patients who do not speak Turkish Patients on routine opioid use

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Groups will be determined according to frailty status.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-frail<br>FRAIL scale= 0 | Device: Patient-controlled analgesia pump (PCA)<br>* Each patient will receive a PCA pump with intravenous (i.v.) morphine.<br>|
| Active Comparator: Pre_frail<br>FRAIL scale= 1-2 | Device: Patient-controlled analgesia pump (PCA)<br>* Each patient will receive a PCA pump with intravenous (i.v.) morphine.<br>|
| Active Comparator: Frail<br>FRAIL scale >2 | Device: Patient-controlled analgesia pump (PCA)<br>* Each patient will receive a PCA pump with intravenous (i.v.) morphine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Total opioid consumption (24 hours) | Postoperative 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scores (VAS) | VAS scores will evaluate at rest and during 45° active knee flexion | 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. | Postoperative for 24 hours |