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脂质体布比卡因(EXPAREL®)在单机构快速通道出院方案中用于接受回肠造口术逆转的患者的延长疼痛缓解:一项 IMPROVE 四期健康经济学试验。

Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial.

机构信息

Department of Colorectal Surgery, Cleveland Clinic, Digestive Disease Institute, Department of Colorectal Surgery, Cleveland, OH, USA.

出版信息

J Pain Res. 2013 Jul 29;6:605-10. doi: 10.2147/JPR.S46950. Print 2013.

Abstract

BACKGROUND

Postoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol.

METHODS

In this single-center, open-label study, patients undergoing ileostomy reversal received postsurgical pain therapy via multimodal analgesia that included a single intraoperative administration of liposome bupivacaine or opioid-based patient-controlled analgesia (PCA) with intravenous morphine or hydromorphone. Rescue analgesia (intravenous [IV] opioids and/or oral opioid + acetaminophen) was available to all patients. Primary efficacy measures included postsurgical opioid use, hospital length of stay (LOS), and hospitalization costs. Secondary measures included: time to first rescue opioid use; patient satisfaction with analgesia; additional medical intervention; and opioid-related adverse events.

RESULTS

Forty-three patients were enrolled and met eligibility criteria (IV opioid PCA group = 20; liposome bupivacaine-based multimodal analgesia group = 23). Postsurgical opioid use was significantly less in the multimodal analgesia group compared with the IV opioid PCA group (mean [standard deviation]: 38 mg [46 mg] versus 68 mg [47 mg]; P = 0.004). Postsurgical LOS between-group differences (median: 3.0 days versus 3.8 days) and geometric mean hospitalization costs (US $6,611 versus US$6,790) favored the multimodal analgesic group but did not achieve statistical significance. Median time to first opioid use was 1.1 hours versus 0.7 hours in the multimodal analgesia and IV opioid PCA groups, respectively; P = 0.035. Two patients in the multimodal analgesia group and one in the IV opioid PCA group experienced opioid-related adverse events.

CONCLUSION

A liposome bupivacaine-based multimodal analgesic regimen reduced postoperative opioid consumption in patients undergoing ileostomy reversal under a fast-track discharge protocol. A reduction of 21% in LOS (0.8 days) was noted which, although not statistically significant, may be considered clinically meaningful given the already aggressive fast-track discharge program.

摘要

背景

回肠造口术逆转术后阿片类药物的使用会导致术后肠梗阻。我们评估了基于脂质体布比卡因的阿片类药物节约型多模式镇痛方案与基于标准阿片类药物的镇痛方案对术后阿片类药物使用的影响。我们还评估了我们机构中接受回肠造口术逆转的患者的健康经济学结果,该机构采用了强化康复出院方案。

方法

在这项单中心、开放标签研究中,接受回肠造口术逆转的患者通过多模式镇痛接受术后疼痛治疗,其中包括单次术中给予脂质体布比卡因或静脉注射吗啡或氢吗啡酮的基于阿片类药物的患者自控镇痛(PCA)。所有患者均可使用解救镇痛(静脉注射[IV]阿片类药物和/或口服阿片类药物+对乙酰氨基酚)。主要疗效指标包括术后阿片类药物使用、住院时间(LOS)和住院费用。次要指标包括:首次解救阿片类药物使用时间;患者对镇痛的满意度;其他医疗干预;以及阿片类药物相关的不良反应。

结果

43 名患者符合入选标准并接受了评估(IV 阿片类药物 PCA 组=20;基于脂质体布比卡因的多模式镇痛组=23)。与 IV 阿片类药物 PCA 组相比,多模式镇痛组术后阿片类药物使用量显著减少(平均[标准差]:38mg[46mg]与 68mg[47mg];P=0.004)。组间术后 LOS 差异(中位数:3.0 天与 3.8 天)和几何均数住院费用(US$6611 与 US$6790)有利于多模式镇痛组,但未达到统计学意义。多模式镇痛组和 IV 阿片类药物 PCA 组首次使用阿片类药物的中位时间分别为 1.1 小时和 0.7 小时;P=0.035。多模式镇痛组有 2 名患者和 IV 阿片类药物 PCA 组有 1 名患者发生阿片类药物相关不良反应。

结论

在快速通道出院方案下,基于脂质体布比卡因的多模式镇痛方案可减少回肠造口术逆转术后阿片类药物的使用。观察到 LOS 减少 21%(0.8 天),虽然没有统计学意义,但鉴于已经采用了积极的快速通道出院方案,这可能被认为具有临床意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e19/3735342/78707e55ba9f/jpr-6-605Fig1.jpg

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