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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000014624
• Date of registration: 23/07/2014
• Prospective Registration: Yes
• Primary sponsor: Mito medical center, Mito Kyodo General Hospital, University of Tsukuba
• Public title: Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.
• Scientific title: Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. - EPOCA
• Date of first enrolment: 2014/09/01
• Target sample size: 120
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015955
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase IV

Countries of recruitment

Japan

Contacts

• Name: Takeo Mammoto
• Affiliation: Mito medical center, Mito Kyodo General Hospital, University of Tsukuba Department of Orthopaedic Surgery and Sports Medicine

• Name: Takeo Mammoto
• Affiliation: Mito medical center, Mito Kyodo General Hospital, University of Tsukuba Department of Orthopaedic Surgery and Sports Medicine

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Osteoarthritis, Rheumatoid arthritis

Intervention(s)

Administration of celecoxib from 2 hours after TKA surgery
Administration of celecoxib from 2 days after TKA surgery

Primary Outcome(s)

VAS pain score on the second day after TKA

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Pfizer Japan Inc.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/12/2016