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The Effects of Frailty on Opioid Consumption

Primary Purpose

Frailty, Opioid Use, Knee Arthropathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient-controlled analgesia pump (PCA)
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Non-frail

    Pre_frail

    Frail

    Arm Description

    FRAIL scale= 0

    FRAIL scale= 1-2

    FRAIL scale >2

    Outcomes

    Primary Outcome Measures

    Opioid consumption
    Total opioid consumption (24 hours)

    Secondary Outcome Measures

    Visual analog pain scores (VAS)
    VAS scores will evaluate at rest and during 45° active knee flexion
    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.

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    July 5, 2022
    Sponsor
    Selcuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05445700
    Brief Title
    The Effects of Frailty on Opioid Consumption
    Official Title
    The Effects of Frailty on Opioid Consumption After Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Selcuk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frailty, Opioid Use, Knee Arthropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Groups will be determined according to frailty status.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-frail
    Arm Type
    Active Comparator
    Arm Description
    FRAIL scale= 0
    Arm Title
    Pre_frail
    Arm Type
    Active Comparator
    Arm Description
    FRAIL scale= 1-2
    Arm Title
    Frail
    Arm Type
    Active Comparator
    Arm Description
    FRAIL scale >2
    Intervention Type
    Device
    Intervention Name(s)
    Patient-controlled analgesia pump (PCA)
    Intervention Description
    Each patient will receive a PCA pump with intravenous (i.v.) morphine.
    Primary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    Total opioid consumption (24 hours)
    Time Frame
    Postoperative 24th hour
    Secondary Outcome Measure Information:
    Title
    Visual analog pain scores (VAS)
    Description
    VAS scores will evaluate at rest and during 45° active knee flexion
    Time Frame
    6,12 and 24 hours
    Title
    Nausea and vomiting questionnaire
    Description
    Postoperative nausea and vomiting will be evaluated by asking the patient whether she/he has had nausea and vomiting for 24 hours.
    Time Frame
    Postoperative for 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mehmet SARGIN, Associate Professor
    Phone
    +90 (332) 241 50 00
    Email
    mehmet21sargin@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effects of Frailty on Opioid Consumption

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