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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Cold Therapy
• Intervention / Treatment: Other: cold therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fatma gök; Phone Number: 05544906142; Email: fatmagok123@gmail.com

Study Locations

• Turkey
  • Karaman
    • Merkez, Karaman, Turkey, 70100
      • Recruiting
      • Karamanoğlu Mehmet bey Üniversitesi
      • Contact: fatma gök; Phone Number: 05544906142; Email: fatmagok123@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental arm; 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.	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.
No Intervention: control arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Collaborators: Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pain; knee arthroplasty; patient; cold therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: KaramanogluMehmetbeyUFGok

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No