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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05445700
Other study ID # 2022-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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