The Effects of Frailty on Opioid Consumption

Frailty Clinical Trial

Official title:

The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05445700
• Other study ID #: 2022-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2022
• Source: Selcuk University
• Contact: Mehmet SARGIN, Associate Professor
• Phone: +90 (332) 241 50 00
• Email: mehmet21sargin[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Knee Arthropathy
• Opioid Use

Intervention

Device:
• Patient-controlled analgesia pump (PCA)
Each patient will receive a PCA pump with intravenous (i.v.) morphine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Total opioid consumption (24 hours)	Postoperative 24th hour
Secondary	Visual analog pain scores (VAS)	VAS scores will evaluate at rest and during 45° active knee flexion	6,12 and 24 hours
Secondary	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