DEX-2-TKA-全膝关节置换术后两次使用地塞米松治疗疼痛：一项随机、盲法、三组多中心临床试验的详细统计分析计划。
DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial.
机构信息
Department of Anaesthesiology, Naestved-Slagelse-Ringsted Hospitals, Naestved, Denmark.
Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
出版信息
Acta Anaesthesiol Scand. 2020 Jul;64(6):839-846. doi: 10.1111/aas.13560. Epub 2020 Mar 3.
BACKGROUND
Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the "DEXamethasone twice for pain treatment after TKA" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled.
METHODS
"DEXamethasone twice for pain treatment after TKA" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and 48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively.
DISCUSSION
The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen.
TRIAL REGISTRATION
EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).
背景
优化术后疼痛治疗至关重要。多模式镇痛是术后疼痛治疗的主要原则，但最佳镇痛组合的证据尚不清楚。通过“DEXamethasone 两次用于 TKA 后疼痛治疗”试验，我们旨在研究单次或两次给予糖皮质激素对全膝关节置换术后疼痛治疗的作用。为了确保透明度和最小化偏倚，我们在最后一名参与者入组前公布了这份带有详细统计分析计划的文章。
方法
“DEXamethasone 两次用于 TKA 后疼痛治疗”（DEX-2-TKA）是一项随机、双盲、三组多中心临床试验。参与者将被随机分配到以下三个干预组之一：单次静脉注射地塞米松 24 毫克、连续两次静脉注射地塞米松 24 毫克或匹配的静脉注射安慰剂。所有三组干预组均将接受扑热息痛、非甾体抗炎药（布洛芬）和局部浸润镇痛。参与者、治疗提供者、结局评估者、数据管理员、统计人员和结论起草者将对分配的干预措施进行盲法。主要结局是术后 0-48 小时内总阿片类药物消耗量（静脉注射吗啡毫克当量）。次要结局是：（1）视觉模拟评分疼痛水平：（a）术后 24 和 48 小时主动膝关节 45 度屈曲时，（b）术后 24 和 48 小时休息时，和（c）0-24 小时（最高评分）和 24-48 小时（最高评分）；（2）术后 48 小时内发生 1 次或 1 次以上不良事件的参与者比例。
讨论
DEX-2-TKA 试验将提供关于在多模式镇痛方案中添加单次或两次高剂量地塞米松的益处和危害的高质量数据。
试验注册
EudraCT：2018-001099-39（2018 年 6 月 8 日至 18 日）；ClinicalTrials.gov：NCT03506789（2019 年 4 月 24 日）。
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