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连接球囊泵用于术后硬膜外镇痛时弹性体患者自控模块的疗效:一项随机非劣效性试验。

The efficacy of elastomeric patient-control module when connected to a balloon pump for postoperative epidural analgesia: A randomized, noninferiority trial.

作者信息

Kim Myung Hwa, Shim Yon Hee, Kim Min-Soo, Shin Yang-Sik, Lee Hyun Joo, Lee Jeong Soo

机构信息

aDepartment of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital bDepartment of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul cDepartment of Anesthesiology and Pain Medicine, CHA Bundang Medical Centre, CHA University, Seongnam, Republic of Korea.

出版信息

Medicine (Baltimore). 2017 Jan;96(2):e5828. doi: 10.1097/MD.0000000000005828.

DOI:10.1097/MD.0000000000005828
PMID:28079812
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5266174/
Abstract

When considering the principles of a pain control strategy by patients, reliable administration of additional bolus doses is important for providing the adequate analgesia and improving patient satisfaction. We compared the efficacy of elastomeric patient-control module (PCM) with conventional PCM providing epidural analgesia postoperatively.A noninferiority comparison was used. Eighty-six patients scheduled for open upper abdominal surgery were randomized to use either an elastomeric or conventional PCM connected to balloon pump. After successful epidural catheter insertion at T6-8 level, fentanyl (15-20 μg/kg) in 0.3% ropivacaine 100 mL was administered at basal rate 2 mL/h with bolus 2 mL and lock-out time 15 minutes. The primary outcome was the verbal numerical rating score for pain.The 95% confidence intervals for differences in pain scores during the first 48 hours postoperatively were <1, indicating noninferiority of the elastomeric PCM. The duration of pump reservoir exhaustion was shorter for the elastomeric PCM (mean [SD], 33 hours [8 hours] vs 40 hours [8 hours], P = 0.0003). There were no differences in the frequency of PCM use, additional analgesics, or adverse events between groups.The elastomeric PCM was as effective as conventional PCM with and exhibited a similar safety profile.

摘要

在考虑患者疼痛控制策略的原则时,可靠地给予额外的推注剂量对于提供充分的镇痛和提高患者满意度很重要。我们比较了弹性体患者自控模块(PCM)与提供术后硬膜外镇痛的传统PCM的疗效。采用非劣效性比较。86例计划行上腹部开放手术的患者被随机分配使用连接球囊泵的弹性体或传统PCM。在T6-8水平成功插入硬膜外导管后,以2 mL/h的基础速率、2 mL的推注量和15分钟的锁定时间给予100 mL 0.3%罗哌卡因中的芬太尼(15-20 μg/kg)。主要结局是疼痛的言语数字评分。术后48小时内疼痛评分差异的95%置信区间<1,表明弹性体PCM不劣于传统PCM。弹性体PCM的泵储液器耗尽持续时间较短(平均[标准差],33小时[8小时]对40小时[8小时],P = 0.0003)。两组之间在PCM使用频率、额外镇痛药或不良事件方面没有差异。弹性体PCM与传统PCM一样有效,并且具有相似的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/976484aa2048/medi-96-e5828-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/4fb7de4bf295/medi-96-e5828-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/c67c85088781/medi-96-e5828-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/a94a385aa6eb/medi-96-e5828-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/976484aa2048/medi-96-e5828-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/4fb7de4bf295/medi-96-e5828-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/44e3d7cd587f/medi-96-e5828-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/c67c85088781/medi-96-e5828-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/a94a385aa6eb/medi-96-e5828-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fba0/5266174/976484aa2048/medi-96-e5828-g008.jpg

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