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

BMJ Open - Tập 10 Số 1 - Trang e030501 - 2020
Qianyu Zhuang1, Liyuan Tao2, Jin Lin1, Jin Jin1, Wenwei Qian1, Yanyan Bian1, Yu-Long Li1, Yulei Dong1, Xisheng Weng1, Ye Li1, Yu Fan1, Wei Wang1, Bin Feng1, Na Gao1, Tiezheng Sun1, Jianhao Lin1, Miaofeng Zhang3, Shigui Yan3, Bin Shen4, Fuxing Pei4
1Department of Orthopedics, Peking Union Medical College Hospital, Beijing, China
2Research Center of Clinical Epidemiology, Peking University 3rd Hospital, Beijing, China
3Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University, Zhejiang, China
4Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China

Tóm tắt

ObjectivesTo 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.DesignDouble-blind, pragmatic, randomised, placebo-controlled trial.SettingFour tertiary hospitals in China.Participants246 consecutive patients who underwent elective unilateral TKA because of osteoarthritis (OA).InterventionsPatients 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 measuresThe 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.ResultsThe 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.ConclusionsThe 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 numberClinicalTrials.gov (ID:NCT02198924).

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Tài liệu tham khảo

Glyn-Jones, 2015, Osteoarthritis, The Lancet, 386, 376, 10.1016/S0140-6736(14)60802-3

Carr, 2012, Knee replacement, The Lancet, 379, 1331, 10.1016/S0140-6736(11)60752-6

Thomazeau, 2016, Acute pain factors predictive of post-operative pain and opioid requirement in multimodal analgesia following knee replacement, Eur J Pain, 20, 822, 10.1002/ejp.808

Lee, 2017, Comprehensive analysis of pain management after total knee arthroplasty, Knee Surg Relat Res, 29, 80, 10.5792/ksrr.16.024

Gaffney, 2017, Perioperative pain management in hip and knee arthroplasty, Orthop Clin North Am, 48, 407, 10.1016/j.ocl.2017.05.001

Turnbull, 2017, Anesthesia for the patient undergoing total knee replacement: current status and future prospects, Local Reg Anesth, 10, 1, 10.2147/LRA.S101373

Khademi, 2016, Opioid therapy and its side effects: a review, Arch Iran Med, 19, 870

Nicholson, 2017, Economic and clinical burden of opioid-induced nausea and vomiting, Postgrad Med, 129, 111, 10.1080/00325481.2017.1243004

Karlsen, 2017, Postoperative pain treatment after total knee arthroplasty: a systematic review, PLoS One, 12, 10.1371/journal.pone.0173107

Moucha, 2016, Current strategies in anesthesia and analgesia for total knee arthroplasty, J Am Acad Orthop Surg, 24, 60, 10.5435/JAAOS-D-14-00259

Zhuang, 2016, 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, BMJ Open, 6, 10.1136/bmjopen-2016-011732

Symonds, 2015, Validation of the Chinese Western Ontario and McMaster universities osteoarthritis index in patients from mainland China with osteoarthritis of the knee, Arthritis Care Res, 67, 1553, 10.1002/acr.22631

Liu, 2015, Translation and validation of the simplified Chinese new knee Society scoring system, BMC Musculoskelet Disord, 16, 10.1186/s12891-015-0854-1

Wang, 2012, Validation of the EQ-5D in a general population sample in urban China, Qual Life Res, 21, 155, 10.1007/s11136-011-9915-6

10.1097/00000542-200603000-00020

Jakobsen, 2017, When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts, BMC Med Res Methodol, 17, 10.1186/s12874-017-0442-1

10.1002/sim.1479

10.1097/00000658-200007000-00008

Ding J , Sun B , Song P , et al . The application of enhanced recovery after surgery (ERAS)/fast-track surgery in gastrectomy for gastric cancer: a systematic review and meta-analysis. Oncotarget 2017;8.doi:10.18632/oncotarget.18581

Mohsina S , Shanmugam D , Sureshkumar S , et al . Adapted eras pathway vs. standard care in patients with perforated duodenal ulcer-a randomized controlled trial. J Gastrointest Surg 2018;22.doi:10.1007/s11605-017-3474-2

Beverly, 2017, Essential elements of multimodal analgesia in enhanced recovery after surgery (ERAS) guidelines, Anesthesiol Clin, 35, e115, 10.1016/j.anclin.2017.01.018

10.1007/s00264-010-0973-0

Athanasakis, 2013, A cost-effectiveness analysis of parecoxib in the management of postoperative pain in the Greek health care setting, Clin Ther, 35, 1118, 10.1016/j.clinthera.2013.06.004

10.1056/NEJMoa1611593

Chan, 2017, Gastrointestinal safety of celecoxib versus naproxen in patients with cardiothrombotic diseases and arthritis after upper gastrointestinal bleeding (concern): an industry-independent, double-blind, double-dummy, randomised trial, The Lancet, 389, 2375, 10.1016/S0140-6736(17)30981-9

10.1097/00000542-200304000-00023

10.1097/00000539-200109000-00036

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BMJ Open

Tập 10 Số 1

e030501

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