优化胺的使用,以减少女性进行乳腺切除为瘤指示的慢性术后疼痛:KALPAS多中心随机对照试验的研究协议
Jing Wang1,2, Lisa V Doan3, Deborah Axelrod4
1Department of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA. jing.wang2@nyulangone.org.
Trials
|January 19, 2024
概括
这项研究调查了胺.
科学领域:
- 麻醉学和疼痛管理
- 手术瘤学手术瘤学
- 药理学 药理学是指药理学的学科.
背景情况:
- 乳腺切除术后疼痛综合征 (PMPS) 影响25-60%的乳腺切除术后患者,影响恢复,并可能导致慢性阿片类药物使用.
- 目前的多模式止痛疗法在乳房切除术后提供有限的预防慢性术后疼痛 (CPSP).
- 迫切需要有效的干预措施来减少CPSP和PMPS,特别是考虑到女性对阿片类药物依赖的增加.
研究的目的:
- 评估胺在预防乳腺切除术后疼痛综合征 (PMPS) 的有效性.
- 评估胺胺在乳腺切除术后减少慢性术后疼痛 (CPSP) 和相关阿片类药物使用的潜力.
- 探索胺对情绪的影响及其在外科手术期间疼痛管理中的作用.
主要方法:
- 一个第三阶段,多中心,随机,安慰剂控制,双盲试验 (KALPAS) 正在评估胺在减少PMPS的有效性.
- 这项研究比较了连续的外科手术期间胺注射,单剂量胺和安慰剂.
- 参与者被监测了一年,主要结果是手术后三个月的疼痛严重程度.
主要成果:
- 主要结局:手术后三个月的疼痛严重程度,使用简要的疼痛清单-简短的形式.
- 二次结果可能包括疼痛减轻,阿片类药物消费和生活质量测量.
- 这项研究旨在提供关于胺在这种情况下的有效性和安全性的可靠数据.
结论:
- 这项研究是NIH帮助结束成长期 (HEAL) 倡议的一部分,旨在解决阿片类药物危机.
- 这些发现可能会显著影响乳腺切除术患者的术后疼痛管理策略.
- 这项研究旨在通过改善疼痛控制来提供一种新的方法来打击阿片类药物流行病.
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