Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty

• Register: ChiCTR
• Last refreshed on: 19 February 2018
• Main ID: ChiCTR1800014872
• Date of registration: 2018-02-12
• Prospective Registration: Yes
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty
• Scientific title: Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial
• Date of first enrolment: 2018-03-01
• Target sample size: Experimental group:50;Control group:50;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=25358
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Longchao Wang
• Affiliation: Chinese Academy of Medical Sciences & Peking Union

• Name: Xisheng Weng
• Affiliation: Chinese Academy of Medical Sciences & Peking Union

Key inclusion & exclusion criteria

Inclusion criteria: 1) Hospitalized patients over the age of 18 with intact cognitive function, no gender restriction;
2) Diagnosed as osteoarthritis (OA) or rheumatoid arthritis (RA) before operation, with unsatisfactory response to conservative treatment;
3) No obvious deformities and unilateral TKA was scheduled;
4) American Society of Anesthesiologists (ASA) = 2;
5) Post-stabilizing prosthesis was implanted;
6) An unified configuration of PCA pump was applied postoperatively.
Exclusion criteria: 1) Allergic to parecoxib sodium, or any composite of the parecoxib sodium product.
2) History of severe allergic reaction, especially dermatological manifestations, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, or known history of allergic to sulfamides;
3) Active gastrointestinal bleeding or ulceration;
4) Allergic to NSAIDS (including COX-2 inhibitors);
5) Pregnancy or breast-feeding;
6) Severe liver dysfunction (serum albumin < 25 g/L, or Child-Pugh score = 10);
7) Inflammatory bowel disease;
8) Congestive heart failure [New York Heart Association (NYHA) II to IV];
9) Ischemic cardiac diseases;
10) Disease of peripheral arteries or cerebral vessels;
11) Severe varus or valgus deformity and flexion deformity.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

osteoarthritis or rheumatoid arthritis

Intervention(s)

Experimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia;

Primary Outcome(s)

Visual analogue scale;

Secondary Outcome(s)

Morphine consumption of postoperative intravenous patient-controlled analgesia;Rescue analgesia consumption;Postoperative knee function;

Source(s) of Monetary Support

Beijing science and Technology Commission of China

Ethics review

Status: Approved
Approval date:
Contact: