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The Effects of Frailty on Opioid Consumption

The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05445700
Enrollment
75
Registered
2022-07-06
Start date
2022-07-15
Completion date
2022-09-15
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Knee Arthropathy, Opioid Use

Brief 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. 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.

Interventions

DEVICEPatient-controlled analgesia pump (PCA)

Each patient will receive a PCA pump with intravenous (i.v.) morphine.

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Groups will be determined according to frailty status.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumptionPostoperative 24th hourTotal opioid consumption (24 hours)

Secondary

MeasureTime frameDescription
Visual analog pain scores (VAS)6,12 and 24 hoursVAS scores will evaluate at rest and during 45° active knee flexion
Nausea and vomiting questionnairePostoperative for 24 hoursPostoperative nausea and vomiting will be evaluated by asking the patient whether she/he has had nausea and vomiting for 24 hours.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026