Efficacy and safety of Postoperative Intravenous Parecoxib sodium Followed by ORal CElecoxib (PIPFORCE) post-total knee arthroplasty in patients with osteoarthritis: a study protocol for a multicentre, double-blind, parallel-group trial.
Total knee arthroplasty (TKA) has been regarded as a most painful orthopaedic surgery. Although many surgeons sequentially use parecoxib and celecoxib as a routine strategy for postoperative pain control after TKA, high quality evidence is still lacking to prove the effect of this sequential regimen, especially at the medium-term follow-up. The purpose of this study, therefore, is to evaluate efficacy and safety of postoperative intravenous parecoxib sodium followed by oral celecoxib in patients with osteoarthritis (OA) undergoing TKA. The hypothesis is that compared to placebo with opioids as rescue treatment, sequential use of parecoxib and celecoxib can achieve less morphine consumption over the postoperative 2 weeks, as well as better pain control, quicker functional recovery in the postoperative 6 weeks and less opioid-related adverse events during the 12-week recovery phase.



This study is designed as a multicentre, randomised, double-blind, parallel-group and placebo-controlled trial. The target sample size is 246. All participants who meet the study inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either the parecoxib/celecoxib group or placebo group. The randomisation and allocation will be study site based. The study will consist of three phases: an initial screening phase; a 6-week double-blind treatment phase; and a 6-week follow-up phase. The primary end point is cumulative opioid consumption during 2 weeks postoperation. Secondary end points consist of the postoperative visual analogue scale score, knee joint function, quality of life, local skin temperature, erythrocyte sedimentation rate, C reactive protein, cytokines and blood coagulation parameters. Safety end points will be monitored too.



Ethics approval for this study has been obtained from the Ethics Committee, Peking Union Medical College Hospital, China (Protocol number: S-572) Study results will be available as published manuscripts and presentations at national and international meetings.



NCT02198924.
Department of Orthopaedics, Peking Union Medical College Hospital, Beijing, China.
Qianyu
Q
Zhuang
Department of Orthopaedics, Peking Union Medical College Hospital, Beijing, China.
Yanyan
Y
Bian
Department of Orthopaedics, Peking Union Medical College Hospital, Beijing, China.
Wei
W
Wang
Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences Chinese Academy of Medical Sciences/School of Basic Medicine, Peking Union Medical College, Beijing, China.
Jingmei
J
Jiang
Department of Orthopaedics, Peking Union Medical College Hospital, Beijing, China.
Bin
B
Feng
Department of Orthopaedics, Peking University People's Hospital, Beijing, China.
Tiezheng
T
Sun
Department of Orthopaedics, Peking University People's Hospital, Beijing, China.
Jianhao
J
Lin
Department of Orthopaedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang Province, China.
Miaofeng
M
Zhang
Department of Orthopaedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang Province, China.
Shigui
S
Yan
Department of Orthopaedics, West China Hospital, Sichuan University, Sichuan, China.
Bin
B
Shen
Department of Orthopaedics, West China Hospital, Sichuan University, Sichuan, China.
Fuxing
F
Pei
Department of Orthopaedics, Peking Union Medical College Hospital, Beijing, China.
Xisheng
X
Weng
D000284:Administration, Oral; D019645:Arthroplasty, Replacement, Knee; D000068579:Celecoxib / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007275:Injections, Intravenous; D007555:Isoxazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D010003:Osteoarthritis / Q000601:surgery*; D010149:Postoperative Pain / Q000188:drug therapy*; D011182:Postoperative Care / Q000379:methods; D012107:Research Design; D016896:Treatment Outcome
D052246:Cyclooxygenase 2 Inhibitors; D007555:Isoxazoles; C409945:parecoxib; D000068579:Celecoxib
celecoxib; cumulative opioid consumption; opioid sparing; parecoxib; postoperative pain; total knee arthroplasty