Comparisons of Parenteral and Enteral COX-2 inhibitors for Post-operative pain of TKA, a prospective non-inferiority randomized double-blinded controlled trial

Phase 4

• Conditions: none; Parecoxib, Celecoxib, Post- operative pain, Total knee arthroplasty

• Registration Number: TCTR20180618002
• Lead Sponsor: Songklanagarind hospital prince of songkla university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-18
• Study Completion: 2020-06-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients who is primary osteoarthritis had failed conservative treatment and decided to undergo Total knee surgery.
2. Age over 55 years

Exclusion Criteria

1. Research participants who had allergy to paracetamol, Aspirin, Sulfonamide drug or NSAIDs(Celecoxib or Parecoxib), Opioids
2. Research participants who had Peptic ulcer disease or Inflammatory bowel disease
3. Research participants who had Chronic rheumatoid arthritis
4. Research participants who had Chronic kidney disease[eGFR < 60 mL/min/1.73m2]
5. Research participants who had Heart ischemia
6. Research participants who had Stoke or brain ischemia
7. Research participants who had Primary or seconary cancer
8. Research participants who had Psychotic disease
9. Research participants who had Asthma or Bronchospasm with treat Steroid
10. Research participantsvwho had cognitive impairment
11. Research participants who had American Society of Anesthesiologists (ASA) grade 4â€5
12. Research participants were unable to communicate and cooperate with the researcher.
13. Research participants who had under spinal block anesthesia .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain 6 hour, 12hour , 24 hours and 48 hours after TKA Pain score

Secondary Outcome Measures

Name	Time	Method
Fentanyl comsumption 24 hours and 48 hours total doses of Fentanyl,Nausea and Vomitting 48 hours number of times,Blood loss 6 hours after surgery milliliter ; modification of the Gross formula,Creatinine Post-op day 3 mg/dL,Creatinine Post-op day 3 mg/dL,ROM of knee Post-op day 1 , Post-op day 2 Goniometer, degrees,Time to walk Still stay hospital hours,Hospital stay When patient is discharge hours,Knee and Osteoarthritis Outcome Score(KOOS) F/U 2 wks , 6 wks after surgery score