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

Karamanoğlu Mehmetbey University

Status: Enrolling

Conditions: Pain, Postoperative; Cold Therapy

Treatments: Other: cold therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06262022

KaramanogluMehmetbeyUFGok

Details and patient eligibility

About

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).

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

experimental arm

Experimental group

Description:

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.

Treatment:

Other: cold therapy

control arm

No Intervention group

Description:

Only unit-specific routine treatment and care interventions will be applied to the patients in the control arm by the team in the unit, and no intervention will be applied by the researcher.