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OpenTrials
Completed

NCT Number: NCT05445700

The Effects of Frailty on Opioid Consumption

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.

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Key information

Conditions

Frailty Knee Arthropathy Opioid Use Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Medical Faculty Hospital

Konya, 42090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-controlled analgesia pump (PCA)

Device

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

Primary outcomes

  1. Opioid consumption

    Time frame: Postoperative 24th hour

    Total opioid consumption (24 hours)

Secondary outcomes

  1. Visual analog pain scores (VAS)

    Time frame: 6,12 and 24 hours

    VAS scores will evaluate at rest and during 45° active knee flexion

  2. Nausea and vomiting questionnaire

    Time frame: Postoperative for 24 hours

    Postoperative nausea and vomiting will be evaluated by asking the patient whether she/he has had nausea and vomiting for 24 hours.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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