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硬膜外吗啡可改善全膝关节置换术后患者的术后镇痛:一项随机对照试验。

Epidural morphine improves postoperative analgesia in patients after total knee arthroplasty: A randomized controlled trial.

机构信息

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.

Department of Biostatistics, Peking University First Hospital, Beijing, China.

出版信息

PLoS One. 2019 Jul 1;14(7):e0219116. doi: 10.1371/journal.pone.0219116. eCollection 2019.

Abstract

BACKGROUND

Patients after total knee arthroplasty (TKA) often develop moderate to severe pain. This study compared the analgesic effect of low-dose epidural morphine vs. a comparable saline injection in patients following TKA surgery.

METHODS

This randomized, double-blinded, and placebo-controlled trial was conducted in a tertiary hospital in Beijing between July 1, 2017 and May 30, 2018. One hundred and ten patients following TKA under combined spinal-epidural anesthesia were randomized to receive either epidural morphine (2 mg diluted to 5 ml normal saline, the epidural morphine group) or placebo (5 ml normal saline, the placebo group). For all patients, single-injection femoral nerve block was performed, and a supplementary patient-controlled intravenous analgesia pump was provided. The severity of pain was assessed with the numerical rating scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) at 6, 12, 24, 36, and 48 hours after surgery. The primary endpoint was moderate to severe pain (NRS pain score ≥4) within 48 hours after surgery.

RESULTS

The percentage with moderate to severe pain within 48 hours was lower in the epidural morphine group than in the placebo group (58.2% [32/55] with epidural morphine vs. 76.4% [42/55] with placebo; OR 0.43, 95% CI 0.19-0.98; p = 0.042). Furthermore, the cumulative morphine consumption within 48 hours was lower (18.4±6.1 mg vs. 22.4±7.3 mg; p = 0.002) whereas the mental component summary score of 30-day quality of life was higher (63.8±2.9 vs. 61.9±4.2; p = 0.008) in the epidural morphine group than in the placebo group.

CONCLUSIONS

For patients following TKA, the addition of epidural morphine to single-injection femoral nerve block improves the quality of analgesia within 48 hours, without increasing adverse events.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03203967.

摘要

背景

全膝关节置换术后(TKA)的患者常出现中重度疼痛。本研究比较了 TKA 术后硬膜外吗啡小剂量与等渗盐水注射的镇痛效果。

方法

这是一项于 2017 年 7 月 1 日至 2018 年 5 月 30 日在北京一家三甲医院进行的随机、双盲、安慰剂对照试验。110 例接受腰硬联合麻醉下行 TKA 的患者被随机分为硬膜外吗啡组(2mg 吗啡稀释至 5ml 生理盐水)或安慰剂组(5ml 生理盐水)。所有患者均接受单次股神经阻滞,并提供补充的患者自控静脉镇痛泵。术后 6、12、24、36 和 48 小时采用数字评分量表(NRS,0 分表示无痛,10 分表示最痛)评估疼痛严重程度。主要终点是术后 48 小时内中重度疼痛(NRS 疼痛评分≥4)。

结果

术后 48 小时内,硬膜外吗啡组中重度疼痛的比例低于安慰剂组(硬膜外吗啡组 58.2%[32/55],安慰剂组 76.4%[42/55];OR 0.43,95%CI 0.19-0.98;p=0.042)。此外,48 小时内累积吗啡消耗量较低(18.4±6.1mg vs. 22.4±7.3mg;p=0.002),硬膜外吗啡组术后 30 天生活质量的心理成分综合评分较高(63.8±2.9 vs. 61.9±4.2;p=0.008)。

结论

对于 TKA 术后患者,单次股神经阻滞中加入硬膜外吗啡可在 48 小时内改善镇痛质量,且不增加不良事件。

试验注册

ClinicalTrials.gov NCT03203967。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6cea/6602200/02566b49288d/pone.0219116.g001.jpg

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