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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200706001
Enrollment
Unknown
Registered
2020-07-06
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Knee osteoarthritis Knee osteoarthritis Osteoarthritis of the knee Gonarthrosis OA knee Total knee arthroplasty Total knee replacement TKA TKR Cold solution irrigation Cold saline irrigation Intraoperative cryo

Interventions

Mixed cold solution&#44
consisted of 0.9% NaCl solution 1000 mL and 10% Povidone iodine 250 mL both were stored at 2&#45
8 degree celsius&#44
irrigation intraoperatively during TKA procedure,Mixed room temperature solution&#44
consisted of 0.9% NaCl solution 1000 mL and 10% Povidone iodine 250 mL both were stored at 25&#45
28 degree celsius&#44
irrigation intraoperatively during TKA procedure
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
Cold solution irrigation,Room temperature soulution irrigation

Sponsors

Research unit
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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&#44; ketorolac&#44; levobupivacaine&#44; morphine&#44; parecoxib&#44; eperisone&#44; paracetamol&#44; codeine&#44; celecoxib&#44; pregabalin) Documented psychiatric or cognitive impairment disorder Documented coagulation disorder Not enough duration of withholding antiplatelet (except low dose aspirin < 162mg/day) /anticoagulant/herb

Design outcomes

Primary

MeasureTime frame
Pain score every 4 hours for 72 hours postoperatively Numeric rating scale 0&#45;10

Secondary

MeasureTime frame
Opioids consumption 72 hours postoperatively Total dose of morphine equivalent per kilogram,Blood loss 72 hours postoperatively Hemoglobin difference&#44; Total drain content&#44; Calculated estimated blood loss (Mercuriali formula)

Countries

Thailand

Contacts

Public ContactPacharapol Udomkiat

Department Orthopedic Surgery&#44; Mahidol University Faculty of Medicine Siriraj Hospital

pudomkiat@hotmail.com+66830383399

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026