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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06262022
Enrollment
78
Registered
2024-02-15
Start date
2024-01-15
Completion date
2024-04-30
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold Therapy, Pain, Postoperative

Keywords

cold therapy, pain, patient, knee arthroplasty

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.

Interventions

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.

Sponsors

Karaman Training and Research Hospital
CollaboratorOTHER
Karamanoğlu Mehmetbey University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
pain levelAfter 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

MeasureTime frameDescription
edemaKnee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.The knee circumference of patients will be measured before total knee arthroplasty and will be measured again at 24 and 48 hours after surgery.
amount of drainageAfter being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.The amount coming from the drain after total knee arthroplasty will be measured

Other

MeasureTime frameDescription
Analgesic consumptionThe first 24 hours and 24-48 hours after total knee arthroplasty. Analgesic consumption between hours will be recorded.The type and amount of analgesics used by patients after total knee arthroplasty will be recorded.

Countries

Turkey (Türkiye)

Contacts

Primary Contactfatma gök
fatmagok123@gmail.com05544906142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026