PMID- 31924632 OWN - NLM STAT- MEDLINE DCOM- 20210210 LR - 20210210 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 10 IP - 1 DP - 2020 Jan 9 TI - Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial. PG - e030501 LID - 10.1136/bmjopen-2019-030501 [doi] LID - e030501 AB - OBJECTIVES: To evaluate the morphine-sparing effects of the sequential treatment versus placebo in subjects undergoing total knee arthroplasty (TKA), the effects on pain relief, inflammation control and functional rehabilitation after TKA and safety. DESIGN: Double-blind, pragmatic, randomised, placebo-controlled trial. SETTING: Four tertiary hospitals in China. PARTICIPANTS: 246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA). INTERVENTIONS: Patients were randomised 1:1 to the parecoxib/celecoxib group or the control group. The patients in the parecoxib/celecoxib group were supplied sequential treatment with intravenous parecoxib 40 mg (every 12 hours) for the first 3 days after surgery, followed by oral celecoxib 200 mg (every 12 hours) for up to 6 weeks. The patients in the control group were supplied with the corresponding placebo under the same instructions. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the cumulative opioid consumption at 2 weeks post operation (intention-to-treat analysis). Secondary endpoints included the Knee Society Score, patient-reported outcomes and the cumulative opioid consumption. RESULTS: The cumulative opioid consumption at 2 weeks was significantly smaller in the parecoxib/celecoxib group than in the control group (median difference, 57.31 (95% CI 34.66 to 110.33)). The parecoxib/celecoxib group achieving superior Knee Society Scores and EQ-5D scores and greater Visual Analogue Scale score reduction during 6 weeks. Interleukin 6, erythrocyte sedation rate and C-reactive protein levels were reduced at 72 hours, 2 weeks and 4 weeks and prostaglandin E2 levels were reduced at 48 hours and 72 hours in the parecoxib/celecoxib group compared with the placebo group. The occurrence of adverse events (AEs) was significantly lower in the parecoxib/celecoxib group. CONCLUSIONS: The sequential intravenous parecoxib followed by oral celecoxib regimen reduces morphine consumption, achieves better pain control and functional recovery and leads to less AEs than placebo after TKA for OA. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (ID: NCT02198924). CI - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Zhuang, Qianyu AU - Zhuang Q AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Tao, Liyuan AU - Tao L AD - Research Center of Clinical Epidemiology, Peking University 3rd Hospital, Beijing, China. FAU - Lin, Jin AU - Lin J AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Jin, Jin AU - Jin J AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Qian, Wenwei AU - Qian W AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Bian, Yanyan AU - Bian Y AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Li, Yulong AU - Li Y AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Dong, Yulei AU - Dong Y AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Peng, Huiming AU - Peng H AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Li, Ye AU - Li Y AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Fan, Yu AU - Fan Y AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Wang, Wei AU - Wang W AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Feng, Bin AU - Feng B AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Gao, Na AU - Gao N AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Sun, Tiezheng AU - Sun T AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Lin, Jianhao AU - Lin J AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China. FAU - Zhang, Miaofeng AU - Zhang M AD - Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang, China. FAU - Yan, Shigui AU - Yan S AD - Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang, China. FAU - Shen, Bin AU - Shen B AD - Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China. FAU - Pei, Fuxing AU - Pei F AD - Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China. FAU - Weng, Xisheng AU - Weng X AUID- ORCID: 0000-0003-0083-5190 AD - Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China wengxishengpumch@126.com. LA - eng SI - ClinicalTrials.gov/NCT02198924 PT - Journal Article PT - Multicenter Study PT - Pragmatic Clinical Trial PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200109 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Cyclooxygenase 2 Inhibitors) RN - 0 (Isoxazoles) RN - 9TUW81Y3CE (parecoxib) RN - JCX84Q7J1L (Celecoxib) SB - IM EIN - BMJ Open. 2020 Mar 9;10(3):e030501corr1. PMID: 32152176 MH - Administration, Intravenous MH - Administration, Oral MH - Aged MH - Arthroplasty, Replacement, Knee/*adverse effects MH - Celecoxib/*administration & dosage MH - Cyclooxygenase 2 Inhibitors/administration & dosage MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Isoxazoles/*administration & dosage MH - Male MH - Osteoarthritis, Knee/*surgery MH - Pain, Postoperative/*drug therapy MH - Postoperative Care/*methods MH - Retrospective Studies MH - Treatment Outcome PMC - PMC6955469 OTO - NOTNLM OT - celecoxib OT - cumulative opioid consumption OT - opioid sparing OT - parecoxib OT - postoperative pain OT - total knee arthroplasty COIS- Competing interests: None declared. EDAT- 2020/01/12 06:00 MHDA- 2021/02/11 06:00 PMCR- 2020/01/09 CRDT- 2020/01/12 06:00 PHST- 2020/01/12 06:00 [entrez] PHST- 2020/01/12 06:00 [pubmed] PHST- 2021/02/11 06:00 [medline] PHST- 2020/01/09 00:00 [pmc-release] AID - bmjopen-2019-030501 [pii] AID - 10.1136/bmjopen-2019-030501 [doi] PST - epublish SO - BMJ Open. 2020 Jan 9;10(1):e030501. doi: 10.1136/bmjopen-2019-030501.