Osteoarthritis, Rheumatoid arthritis
Conditions
Interventions
Administration of celecoxib from 2 hours after TKA surgery
Administration of celecoxib from 2 days after TKA surgery
Sponsors
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient can understand and comply with the protocol and has signed the informed consent document at screening. 2) Patient is over 20 years old at the time of informed consent. 3) Patient undergoing unilateral total knee arthroplasty 4) Patient undergoing TKA surgery in the morning 5) Patient assessed by principal and/or co-investigator for eligibility as pain control with multimodal analgesia including femoral and sciatic nerve blocks and PCA fentanyl after TKA surgery.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS pain score on the second day after TKA | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTakeo Mammoto
Mito medical center, Mito Kyodo General Hospital, University of Tsukuba Department of Orthopaedic Surgery and Sports Medicine
Outcome results
None listed