鞘内氢吗啡酮与鞘内吗啡用于剖宫产后镇痛:一项随机非劣效性试验。

IF 3.8 2区 医学 Q1 ANESTHESIOLOGY
Sonny Cheng, John Bartolacci, Kevin Armstrong, Aldo Dobrowlanski, Philip M Jones, Sudha Indu Singh, Ilana Sebbag
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引用次数: 0

摘要

背景:脊髓麻醉鞘内吗啡通常是选择性剖宫产的首选麻醉方式。然而,副作用和药物短缺促使研究人员研究鞘内氢吗啡酮作为替代方法。这些研究确定了90%的患者使用这两种阿片类药物用于剖宫产后镇痛的有效镇痛剂量(ED90),但未能证明吗啡优于氢吗啡酮。然而,氢吗啡酮的非劣效性尚未确定。方法:在这项非劣效性随机盲法临床试验中,126例在脊髓麻醉下择期剖宫产的患者分别给予吗啡150µg或氢吗啡酮75µg (ED90)。主要结局是剖宫产后最初24小时的平均数值评定量表(NRS)疼痛评分(0-10)的组间差异,预设的非劣效性阈值为1。24小时NRS疼痛评分定义为剖宫产后24小时访谈中获得的单一数字,基于参与者在此期间对其整体疼痛体验的回忆。次要结局包括每6小时NRS疼痛评分、累计24小时阿片类药物消耗、首次使用阿片类药物的时间、通过产科恢复质量评分-11 (ObsQoR-11)衡量的恢复质量、副作用干预频率和Apgar评分的差异。结果:吗啡组24小时NRS疼痛评分的平均值(标准差[SD])为4.0(1.7),氢吗啡酮组为3.6(1.5)(组间差异为-0.46(95%可信区间[CI], -1.0 ~ 0.1)。鉴于95% CI上限不超过1,氢吗啡酮的非劣效性成立。平均(SD) 24小时口服吗啡用量(吗啡:4.2 mg (6.5) vs氢吗啡酮:4.1 (8.0)mg;P = .98),中位数[四分位数间距{IQR}] ObsQoR-11评分(吗啡:87分[75-97.5分]vs氢吗啡酮:90分[80-96.5分];P = .51),第一次阿片类药物请求的中位时间(IQR)(吗啡:10.2 [3.2-15.5]h vs氢吗啡酮:6.2 [3.1-12.4]h;P = 0.35),或阿片类药物相关瘙痒(吗啡:0.316(方差0.216)vs氢吗啡酮:0.321(方差0.218)(P = 0.96)和阿片类药物相关恶心和呕吐(吗啡:0.333(方差0.222)vs氢吗啡酮:0.393(方差0.238)(P = 0.51)需要干预的患者比例。结论:鞘内注射,氢吗啡酮在选择性剖宫产后的镇痛效果不逊于吗啡,使用先前建立的两种阿片类药物的ED90(吗啡:150µg对氢吗啡酮:75µg);氢吗啡酮具有有效的镇痛作用,可能是吗啡的合适替代品。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intrathecal Hydromorphone Versus Intrathecal Morphine for Postcesarean Delivery Analgesia: A Randomized Noninferiority Trial.

Background: Spinal anesthesia with intrathecal morphine is often the preferred anesthetic modality for elective cesarean delivery. Side effects and drug shortages, however, prompted researchers to look into intrathecal hydromorphone as an alternative. These studies established the effective analgesic dose for 90% of patients (ED90) for both opioids for postcesarean analgesia, yet failed to demonstrate the superiority of morphine over hydromorphone. Nonetheless, the noninferiority of hydromorphone has yet to be determined.

Methods: In this noninferiority randomized blinded clinical trial, 126 patients undergoing elective cesarean delivery under spinal anesthesia received either morphine 150 µg or hydromorphone 75 µg (ED90). The primary outcome was the between-group difference of the mean Numeric Rating Scale (NRS) pain score (0-10) for the first 24 hours after cesarean delivery, with a preestablished threshold for noninferiority of 1. This 24-hour NRS pain score was defined as a single number obtained at the 24 hours postcesarean delivery interview, based on participant's recall of their overall pain experience during this period. Secondary outcomes included differences in NRS pain scores every 6 hours, cumulative 24 hour opioid consumption, time-to-first opioid request, quality of recovery as measured by the Obstetric Quality of Recovery Score-11 (ObsQoR-11), frequency of interventions for side effects, and Apgar scores.

Results: The mean (standard deviation [SD]) of the 24-hour NRS pain score was 4.0 (1.7) for morphine and 3.6 (1.5) for hydromorphone (between-group difference -0.46 (95% confidence interval [CI], -1.0 to 0.1). Given that the upper limit of the 95% CI did not exceed 1, noninferiority of hydromorphone was established. No statistically significant differences were found in mean (SD) 24 hour oral morphine consumption (morphine: 4.2 mg (6.5) vs hydromorphone: 4.1 (8.0) mg; P = .98), median [interquartile range {IQR}] ObsQoR-11 score (morphine: score 87 [75-97.5] vs hydromorphone: score 90 [80-96.5]; P = .51), median [IQR] time to first opioid request (morphine: 10.2 [3.2-15.5] h versus hydromorphone: 6.2 [3.1-12.4] h; P = .35), or proportion of patients requiring interventions for opioid-related pruritus (morphine: 0.316 (variance 0.216) vs hydromorphone: 0.321 (variance 0.218) (P = .96) and opioid-related nausea and vomiting (morphine: 0.333 (variance 0.222) vs hydromorphone: 0.393 (variance 0.238) (P = .51).

Conclusions: Intrathecally, hydromorphone is noninferior to morphine for analgesia after elective cesarean delivery when using the previously established ED90 for both opioids (morphine: 150 µg versus hydromorphone: 75 µg); hydromorphone provides effective analgesia and may be a suitable alternative to morphine.

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来源期刊
Anesthesia and analgesia
Anesthesia and analgesia 医学-麻醉学
CiteScore
9.90
自引率
7.00%
发文量
817
审稿时长
2 months
期刊介绍: Anesthesia & Analgesia exists for the benefit of patients under the care of health care professionals engaged in the disciplines broadly related to anesthesiology, perioperative medicine, critical care medicine, and pain medicine. The Journal furthers the care of these patients by reporting the fundamental advances in the science of these clinical disciplines and by documenting the clinical, laboratory, and administrative advances that guide therapy. Anesthesia & Analgesia seeks a balance between definitive clinical and management investigations and outstanding basic scientific reports. The Journal welcomes original manuscripts containing rigorous design and analysis, even if unusual in their approach.
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