The Effect of Cold Application on Pain Level, Edema and Drainage Amount

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262022
• Other study ID #: KaramanogluMehmetbeyUFGok
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Karamanoglu Mehmetbey University
• Contact: fatma gök
• Phone: 05544906142
• Email: fatmagok123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• cold therapy
A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty.

Locations

Country	Name	City	State
Turkey	Karamanoglu Mehmet bey Üniversitesi	Merkez	Karaman

Sponsors (2)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University	Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analgesic consumption	The type and amount of analgesics used by patients after total knee arthroplasty will be recorded.	The first 24 hours and 24-48 hours after total knee arthroplasty. Analgesic consumption between hours will be recorded.
Primary	pain level	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.)	After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.
Secondary	edema	The knee circumference of patients will be measured before total knee arthroplasty and will be measured again at 24 and 48 hours after surgery.	Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.
Secondary	amount of drainage	The amount coming from the drain after total knee arthroplasty will be measured	After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.