The Effects of Frailty on Opioid Consumption

Not Applicable

Completed

• Conditions: Opioid Use; Knee Arthropathy; Frailty
• Interventions: Device: Patient-controlled analgesia pump (PCA)

• Registration Number: NCT05445700
• Lead Sponsor: Selcuk University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-06
• Study Start: 2022-07-15
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patients who will undergo unilateral, primary total knee arthroplasty
• Patients who will be operated with spinal anesthesia

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Exclusion Criteria

• Patients with ASA IV and above physical status
• Uncooperative patients
• Patients who do not speak Turkish
• Patients on routine opioid use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pre_frail	Patient-controlled analgesia pump (PCA)	FRAIL scale= 1-2
Frail	Patient-controlled analgesia pump (PCA)	FRAIL scale \>2
Non-frail	Patient-controlled analgesia pump (PCA)	FRAIL scale= 0

Primary Outcome Measures

Name	Time	Method
Opioid consumption	Postoperative 24th hour	Total opioid consumption (24 hours)

Secondary Outcome Measures

Name	Time	Method
Visual analog pain scores (VAS)	6,12 and 24 hours	VAS scores will evaluate at rest and during 45° active knee flexion
Nausea and vomiting questionnaire	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.

Trial Locations

Locations (1)

Selcuk University Medical Faculty Hospital; 🇹🇷 Konya, Turkey