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髋部骨折手术急性恢复期的术后持续血流冷冻压缩疗法——一项随机对照临床试验

Postoperative continuous-flow cryocompression therapy in the acute recovery phase of hip fracture surgery-A randomized controlled clinical trial.

作者信息

Leegwater Nick C, Bloemers Frank W, de Korte Niels, Heetveld Martin J, Kalisvaart Kees J, Schönhuth Casper P, Pijnenburg Bas A C M, Burger Bart J, Ponsen Kornelis J, Maier Andrea B, van Royen Barend J, Nolte Peter A

机构信息

Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands.

Department of Surgery, Section of Traumasurgery, VU University Medical Centre, Amsterdam, The Netherlands.

出版信息

Injury. 2017 Dec;48(12):2754-2761. doi: 10.1016/j.injury.2017.10.024. Epub 2017 Oct 10.

Abstract

BACKGROUND

The acute recovery phase after hip fracture surgery is often complicated by severe pain, postoperative blood loss with subsequent transfusion, and delirium. Prevalent comorbidity in hip fracture patients limit the use of opioid-based analgesic therapies, yielding a high risk for inferior pain treatment. Postoperative cryotherapy is suggested to provide an analgesic effect, and to reduce postoperative blood loss. In this prospective, open-label, parallel, multicentre, randomized controlled, clinical trial, we aimed to determine the efficacy of continuous-flow cryocompression therapy (CFCT) in the acute recovery phase after hip fracture surgery.

METHODS

Patients with an intra or extracapsular hip fracture scheduled for surgery were included. Subjects were allocated to receive postoperative CFCT or usual care. The primary endpoint was numeric rating scale (NRS) pain the first 72 postoperative hours. Secondly, analgesic use; postoperative haemoglobin change and transfusion incidence; functional outcome; length of stay; delirium incidence; location of rehabilitation; patient-reported health outcome; complications and feasibility were assessed.

RESULTS

Sixty-one subjects in the control group, and 64 subjects in the CFCT group were analysed. Within the CFCT group, post treatment NRS pain declined 0.31 (p=0.07) at 24h, 0.28 (p=0.07) at 48h, and 0.47 (p=0.002) at 72h relative to pre treatment NRS pain. Sensitivity analysis at 72h showed that NRS pain was 0.92 lower in the CFCT group when compared to the control group (1.50 vs. 2.42; p=0.03). Postoperative analgesic use was comparable between groups. Between postoperative day one and three haemoglobin declined 0.29mmol/l in the CFCT group and 0.51mmol/l in controls (p=0.06), and transfusion incidence was comparable. The timed up and go test and length of stay were also comparable between both groups. Complications, amongst delirium and cryotherapy-related adverse events were not statistically significantly different. Discharge locations did not differ between groups. At outpatient follow-up subjects did not differ in patient-reported health outcome scores. Subjects rated CFCT satisfaction with an average of 7.1 out of 10 points.

CONCLUSIONS

No evidence was recorded to suggest that CFCT has an added value in the acute recovery phase after hip fracture surgery. If patients complete the CFCT treatment schedule, a mild analgesic effect is observed at 72h.

摘要

背景

髋部骨折手术后的急性恢复期常伴有严重疼痛、术后失血及随后的输血,还有谵妄。髋部骨折患者普遍存在的合并症限制了基于阿片类药物的镇痛疗法的使用,导致疼痛治疗效果不佳的风险很高。建议术后进行冷冻疗法以提供镇痛效果,并减少术后失血。在这项前瞻性、开放标签、平行、多中心、随机对照临床试验中,我们旨在确定连续流动冷冻压缩疗法(CFCT)在髋部骨折手术后急性恢复期的疗效。

方法

纳入计划接受手术的囊内或囊外髋部骨折患者。受试者被分配接受术后CFCT或常规护理。主要终点是术后头72小时的数字评分量表(NRS)疼痛评分。其次,评估镇痛药物使用情况;术后血红蛋白变化和输血发生率;功能结局;住院时间;谵妄发生率;康复地点;患者报告的健康结局;并发症和可行性。

结果

分析了对照组的61名受试者和CFCT组的64名受试者。在CFCT组中,与治疗前NRS疼痛评分相比,治疗后24小时NRS疼痛评分下降0.31(p = 0.07),48小时下降0.28(p = 0.07),72小时下降0.47(p = 0.002)。72小时的敏感性分析表明,CFCT组的NRS疼痛评分比对照组低0.92(1.50对2.42;p = 0.03)。两组术后镇痛药物使用情况相当。术后第1天至第3天,CFCT组血红蛋白下降0.29mmol/l,对照组下降0.51mmol/l(p = 0.06),输血发生率相当。两组的定时起立行走测试和住院时间也相当。在谵妄和与冷冻疗法相关的不良事件等并发症方面,两组无统计学显著差异。两组出院地点无差异。在门诊随访中,患者报告的健康结局评分在两组间无差异。受试者对CFCT的满意度平均为10分中的7.1分。

结论

没有证据表明CFCT在髋部骨折手术后的急性恢复期具有附加价值。如果患者完成CFCT治疗方案,在72小时时可观察到轻微的镇痛效果。

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