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The Effects of Frailty on Opioid Consumption

NCT ID: NCT05445700

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-09-15

Brief Summary

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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

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Conditions

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Frailty Opioid Use Knee Arthropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Groups will be determined according to frailty status.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Non-frail

FRAIL scale= 0

Group Type ACTIVE_COMPARATOR

Patient-controlled analgesia pump (PCA)

Intervention Type DEVICE

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

Pre_frail

FRAIL scale= 1-2

Group Type ACTIVE_COMPARATOR

Patient-controlled analgesia pump (PCA)

Intervention Type DEVICE

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

Frail

FRAIL scale \>2

Group Type ACTIVE_COMPARATOR

Patient-controlled analgesia pump (PCA)

Intervention Type DEVICE

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

Interventions

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Patient-controlled analgesia pump (PCA)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet SARGIN

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University Medical Faculty Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022-1

Identifier Type: -

Identifier Source: org_study_id