Effect of intraoperative cold solution irrigation to reduce postoperative pain in knee osteoarthritis patients who underwent unilateral primary total knee arthroplasty: A double-blinded randomized controlled trial

Not Applicable

• Conditions: Knee osteoarthritis; Osteoarthritis of the knee; Gonarthrosis; OA knee; Total knee arthroplasty; Total knee replacement; TKA; TKR; Cold solution irrigation; Cold saline irrigation

• Registration Number: TCTR20200706001
• Lead Sponsor: Research unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study Completion: 2022-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Age > 45 years old
Knee osteoarthritis patients who underwent unilateral primary TKA

Exclusion Criteria

Cold intolerance/Cold allergy
History of previous knee surgery deeper than subcutaneous layer
Secondary osteoarthritis from inflammatory joint diseases
Chronic kidney disease eGFR < 50 mL/min/1.73m2
Allergy to/Contraindicated to drug in protocol
(Tranexamic acid, ketorolac, levobupivacaine, morphine, parecoxib, eperisone, paracetamol, codeine, celecoxib, pregabalin)
Documented psychiatric or cognitive impairment disorder
Documented coagulation disorder
Not enough duration of withholding antiplatelet (except low dose aspirin < 162mg/day) /anticoagulant/herb

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score every 4 hours for 72 hours postoperatively Numeric rating scale 0-10

Secondary Outcome Measures

Name	Time	Method
Opioids consumption 72 hours postoperatively Total dose of morphine equivalent per kilogram,Blood loss 72 hours postoperatively Hemoglobin difference, Total drain content, Calculated estimated blood loss (Mercuriali formula)