The Effects of Frailty on Opioid Consumption

NCT05445700 | Completed

• 1 other identifier: 2022-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Opioid Use; Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Total opioid consumption (24 hours)

  Postoperative 24th hour

Secondary Outcomes (2)

• Visual analog pain scores (VAS)

  6,12 and 24 hours

• Nausea and vomiting questionnaire

  Postoperative for 24 hours

Study Arms (3)

Non-frail

ACTIVE COMPARATOR

FRAIL scale= 0

Device: Patient-controlled analgesia pump (PCA)

Pre_frail

ACTIVE COMPARATOR

FRAIL scale= 1-2

Device: Patient-controlled analgesia pump (PCA)

Frail

ACTIVE COMPARATOR

FRAIL scale \>2

Device: Patient-controlled analgesia pump (PCA)

Interventions

Patient-controlled analgesia pump (PCA) DEVICE

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

Frail; Non-frail; Pre_frail

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Medical Faculty Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Groups will be determined according to frailty status.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: July 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)