地塞米松作为多模式疼痛治疗后全膝关节置换术后镇痛辅助药物的效果：随机临床试验。
Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial.
机构信息
Department of Anaesthesiology, Næstved, Slagelse and Ringsted Hospitals, Næstved, Denmark.
Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark.
出版信息
BMJ. 2022 Jan 4;376:e067325. doi: 10.1136/bmj-2021-067325.
OBJECTIVE
To investigate the effects of one and two doses of intravenous dexamethasone in patients after total knee arthroplasty.
DESIGN
Randomised, blinded, placebo controlled trial with follow-up at 90 days.
SETTING
Five Danish hospitals, September 2018 to March 2020.
PARTICIPANTS
485 adult participants undergoing total knee arthroplasty.
INTERVENTION
A computer generated randomised sequence stratified for site was used to allocate participants to one of three groups: DX1 (dexamethasone (24 mg)+placebo); DX2 (dexamethasone (24 mg)+dexamethasone (24 mg)); or placebo (placebo+placebo). The intervention was given preoperatively and after 24 hours. Participants, investigators, and outcome assessors were blinded. All participants received paracetamol, ibuprofen, and local infiltration analgesia.
MAIN OUTCOME MEASURES
The primary outcome was total intravenous morphine consumption 0 to 48 hours postoperatively. Multiplicity adjusted threshold for statistical significance was P<0.017 and minimal important difference was 10 mg morphine. Secondary outcomes included postoperative pain.
RESULTS
485 participants were randomised: 161 to DX1, 162 to DX2, and 162 to placebo. Data from 472 participants (97.3%) were included in the primary outcome analysis. The median (interquartile range) morphine consumptions at 0-48 hours were: DX1 37.9 mg (20.7 to 56.7); DX2 35.0 mg (20.6 to 52.0); and placebo 43.0 mg (28.7 to 64.0). Hodges-Lehmann median differences between groups were: -2.7 mg (98.3% confidence interval -9.3 to 3.7), P=0.30 between DX1 and DX2; 7.8 mg (0.7 to 14.7), P=0.008 between DX1 and placebo; and 10.7 mg (4.0 to 17.3), P<0.001 between DX2 and placebo. Postoperative pain was reduced at 24 hours with one dose, and at 48 hours with two doses, of dexamethasone.
CONCLUSION
Two doses of dexamethasone reduced morphine consumption during 48 hours after total knee arthroplasty and reduced postoperative pain.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03506789.
目的
研究单次和两次静脉注射地塞米松对全膝关节置换术后患者的影响。
设计
随机、盲法、安慰剂对照试验，随访时间为 90 天。
地点
丹麦五家医院，2018 年 9 月至 2020 年 3 月。
参与者
485 名接受全膝关节置换术的成年患者。
干预措施
使用计算机生成的随机序列，根据地点进行分层，将参与者分配到三组之一：DX1（地塞米松（24mg）+安慰剂）；DX2（地塞米松（24mg）+地塞米松（24mg））；或安慰剂（安慰剂+安慰剂）。干预措施在术前和术后 24 小时给予。参与者、研究者和结果评估者均设盲。所有参与者均接受扑热息痛、布洛芬和局部浸润镇痛。
主要结局指标
主要结局是术后 0 至 48 小时内静脉注射吗啡的总消耗量。统计学意义的多重调整阈值为 P<0.017，最小有意义差异为 10mg 吗啡。次要结局包括术后疼痛。
结果
485 名参与者被随机分配：DX1 组 161 名，DX2 组 162 名，安慰剂组 162 名。472 名参与者（97.3%）的数据纳入主要结局分析。0-48 小时吗啡消耗量的中位数（四分位距）为：DX1 组 37.9mg（20.7 至 56.7）；DX2 组 35.0mg（20.6 至 52.0）；安慰剂组 43.0mg（28.7 至 64.0）。组间 Hodges-Lehmann 中位数差异为：-2.7mg（98.3%置信区间-9.3 至 3.7），DX1 与 DX2 之间 P=0.30；7.8mg（0.7 至 14.7），DX1 与安慰剂之间 P=0.008；10.7mg（4.0 至 17.3），DX2 与安慰剂之间 P<0.001。单次和两次使用地塞米松均可降低术后 24 小时的吗啡用量，且在术后 48 小时降低术后疼痛。
结论
全膝关节置换术后 48 小时内两次使用地塞米松可减少吗啡用量，并减轻术后疼痛。
试验注册
Clinicaltrials.gov NCT03506789。
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