Clinical trial NCT06262022: The Effect of Cold Application on Pain Level, Edema and Drainage Amount
Official title: The Effect of Cold Application on Pain Level, Edema and Drainage Amount in Patients With Total Knee Arthroplasty: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cold Therapy
Pain, Postoperative
Keywords: cold therapy
pain
patient
knee arthroplasty
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karaman Training and Research Hospital
First posted: 2024-02-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: pain level
timeFrame: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.
Secondary outcomes:
measure: edema
timeFrame: Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.
measure: amount of drainage
timeFrame: After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.
Other outcomes:
measure: Analgesic consumption
timeFrame: The first 24 hours and 24-48 hours after total knee arthroplasty. Analgesic consumption between hours will be recorded.
Locations:
city: Merkez
country: Turkey
facility: Karamanoğlu Mehmet bey Üniversitesi
state: Karaman
Study officials:
References: