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Clinical Trials/NCT06262022
NCT06262022
Recruiting
N/A

The Effect of Cold Application on Pain Level, Edema and Drainage Amount in Patients With Total Knee Arthroplasty: A Randomized Controlled Study

Karamanoğlu Mehmetbey University1 site in 1 country78 target enrollmentJanuary 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cold Therapy
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
78
Locations
1
Primary Endpoint
pain level
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:

  • Is there a difference between the pain levels of patients in the control and cold application arms?
  • Is there a difference between the knee edema of patients in the control and cold application arms?
  • Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).

Detailed Description

* When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day. * After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours. * Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA. * After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours. * In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded. * Knee temperature will be measured before and after each cold application. * Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Fatma GÖK

lecturer

Karamanoğlu Mehmetbey University

Eligibility Criteria

Inclusion Criteria

  • 18 years and above,
  • Able to communicate verbally and in writing,
  • Turkish speaking,
  • TKA applied for the first time,
  • Unilateral total knee arthroplasty applied,
  • Spinal anesthesia applied,
  • Having a hemovac drainage catheter,
  • Without peripheral vascular disease,

Exclusion Criteria

  • Revision total knee arthroplasty applied,
  • Bilateraltotal knee arthroplasty applied,
  • Those who use alcohol and substances,
  • TKA was performed for a reason other than knee osteoarthritis,
  • General anesthesia applied,

Outcomes

Primary Outcomes

pain level

Time Frame: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.

Pain level of patients will be measured after total knee arthroplasty ( Visual Analogue Scale (VAS) is a 10 cm ruler with "no pain" written on one end and "the worst possible pain" written on the other end. Patients mark the levels on the ruler according to their pain levels. 1-3 points on the scale are rated as mild, 4-6 points as moderate and 7-10 points as severe pain.)

Secondary Outcomes

  • amount of drainage(After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.)
  • edema(Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.)

Study Sites (1)

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