Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.

Phase 4

• Conditions: Osteoarthritis, Rheumatoid arthritis

• Registration Number: JPRN-UMIN000014624
• Lead Sponsor: Mito medical center, Mito Kyodo General Hospital, University of Tsukuba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-23
• Study Completion: 2016-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patient who has a history or complication of hypersensitivity to celecoxib, fentanyl or sulfonamides, and patient who has a history or complication of a serious allergic reaction to any other drugs. 2) Patient who has a history or complication with aspirin-induced asthma. 3) Patient who has a complication of gastrointestinal hemorrhage or ulcer. 4) Patient who has severe hepatic dysfunction. 5) Patient who has severe renal dysfunction. 6) Patient who has severe cardiovascular dysfunction. 7) Patient who is in a perioperative period of coronary artery bypass surgery. 8) Patient who is pregnant, lactating or probably pregnant. 9) Patient who had a drug abuse. 10) Patient who takes or will take an analgetic drug or sleeping drug with the exception of the following drugs from two days before surgery to final evaluation. Ultrashort- acting Hypnotic including triazolam, zopiclone and zolpidem tartrate is permitted until surgery. 11) Patient who is judged not to carry the trial through by principal or co-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS pain score on the second day after TKA

Secondary Outcome Measures

Name	Time	Method
1. Fentanyl consumption through PCA 2. VAS pain score through the following day to the seventh day after surgery 3. Range of motion of the knee joint 4. Evaluation of sleep quality using VAS sleep disturbance 5. Evaluation of sleep quality including sleep latency, sleep efficacy, nocturnal awakening, sleep depth, body motion and the time it takes to deep sleep monitored by SLEEPSCAN. 6. The overall patient satisfaction during the period of medication. 7. The overall evaluation by physician during the period of medication. 8. Incidence rate of postoperative nausea and vomiting, and frequency of taking anti-nausea pills 9. Rescue analgesic consumption (a diclofenac sodium suppository) after the removal of PCA fentanyl.