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Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial

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, plac...

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Autores principales: Zhuang, Qianyu, Tao, Liyuan, Lin, Jin, Jin, Jin, Qian, Wenwei, Bian, Yanyan, Li, Yulong, Dong, Yulei, Peng, Huiming, Li, Ye, Fan, Yu, Wang, Wei, Feng, Bin, Gao, Na, Sun, Tiezheng, Lin, Jianhao, Zhang, Miaofeng, Yan, Shigui, Shen, Bin, Pei, Fuxing, Weng, Xisheng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955469/
https://www.ncbi.nlm.nih.gov/pubmed/31924632
http://dx.doi.org/10.1136/bmjopen-2019-030501
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author Zhuang, Qianyu
Tao, Liyuan
Lin, Jin
Jin, Jin
Qian, Wenwei
Bian, Yanyan
Li, Yulong
Dong, Yulei
Peng, Huiming
Li, Ye
Fan, Yu
Wang, Wei
Feng, Bin
Gao, Na
Sun, Tiezheng
Lin, Jianhao
Zhang, Miaofeng
Yan, Shigui
Shen, Bin
Pei, Fuxing
Weng, Xisheng
author_facet Zhuang, Qianyu
Tao, Liyuan
Lin, Jin
Jin, Jin
Qian, Wenwei
Bian, Yanyan
Li, Yulong
Dong, Yulei
Peng, Huiming
Li, Ye
Fan, Yu
Wang, Wei
Feng, Bin
Gao, Na
Sun, Tiezheng
Lin, Jianhao
Zhang, Miaofeng
Yan, Shigui
Shen, Bin
Pei, Fuxing
Weng, Xisheng
author_sort Zhuang, Qianyu
collection PubMed
description 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).
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spelling pubmed-69554692020-01-27 Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial Zhuang, Qianyu Tao, Liyuan Lin, Jin Jin, Jin Qian, Wenwei Bian, Yanyan Li, Yulong Dong, Yulei Peng, Huiming Li, Ye Fan, Yu Wang, Wei Feng, Bin Gao, Na Sun, Tiezheng Lin, Jianhao Zhang, Miaofeng Yan, Shigui Shen, Bin Pei, Fuxing Weng, Xisheng BMJ Open Surgery 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). BMJ Publishing Group 2020-01-09 /pmc/articles/PMC6955469/ /pubmed/31924632 http://dx.doi.org/10.1136/bmjopen-2019-030501 Text en © 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. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Surgery
Zhuang, Qianyu
Tao, Liyuan
Lin, Jin
Jin, Jin
Qian, Wenwei
Bian, Yanyan
Li, Yulong
Dong, Yulei
Peng, Huiming
Li, Ye
Fan, Yu
Wang, Wei
Feng, Bin
Gao, Na
Sun, Tiezheng
Lin, Jianhao
Zhang, Miaofeng
Yan, Shigui
Shen, Bin
Pei, Fuxing
Weng, Xisheng
Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title_full Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title_fullStr Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title_full_unstemmed Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title_short Postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (PIPFORCE): a multicentre, double-blind, randomised, placebo-controlled trial
title_sort postoperative intravenous parecoxib sodium followed by oral celecoxib post total knee arthroplasty in osteoarthritis patients (pipforce): a multicentre, double-blind, randomised, placebo-controlled trial
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955469/
https://www.ncbi.nlm.nih.gov/pubmed/31924632
http://dx.doi.org/10.1136/bmjopen-2019-030501
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