The Effects of Frailty on Opioid Consumption

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Opioid Use; Knee Arthropathy
• Intervention / Treatment: Device: Patient-controlled analgesia pump (PCA)

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet SARGIN, Associate Professor; Phone Number: +90 (332) 241 50 00; Email: mehmet21sargin@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2022-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No