NCT05910281

Brief Summary

The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

June 9, 2023

Last Update Submit

July 21, 2023

Conditions

Postoperative PainPostoperative ComplicationsPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    postoperative 3-5 days fellow-up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- 18-80 years older age who underwent total knee arthroplasty

You may qualify if:

  • years older age who underwent total knee arthroplasty

You may not qualify if:

  • ASA score 4 or \>4
  • Active infection
  • End stage organ failure
  • Pregnancy
  • Established diagnosis neuropsychiatric disease ( epilepsy, neuropathy, neuromuscular disease, cerebrovascular disease...)
  • Uses of oral corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, None Selected, 10100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePostoperative ComplicationsPostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Central Study Contacts

Bilal Katipoglu

CONTACT

+905543330380drbilal07@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

TU(1)