Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial.
Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial.
复制标题
优化氯胺酮的使用以减少因肿瘤适应症接受乳房切除术的女性的慢性术后疼痛：KALPAS多中心随机对照试验的研究方案
作者：
乳房切除术是常见的手术，与慢性术后疼痛(CPSP)密切相关，更具体地说，被称为乳房切除术后疼痛综合征(PMPS)，25%-60%的患者在手术后3个月报告疼痛。PMPs干扰功能、恢复和辅助治疗的依从性。重要的是，它与慢性阿片类药物的使用有关，因为最近的一项研究表明，每10名患者中就有1名在根治手术后至少3个月继续使用阿片类药物。大多数PMPS患者是女性，在过去的10年里，女性阿片依赖的增长速度超过了男性。标准的围手术期多模式镇痛在预防CPSP方面仅有一定的效果。因此，迫切需要采取干预措施来减少CPSP和PMPS。众所周知，氯胺酮可以改善术后急性期间的疼痛和减少阿片类药物的使用。此外，在焦虑和抑郁的研究中，氯胺酮被证明可以控制情绪。通过在围手术期针对急性疼痛和改善情绪，氯胺酮可能能够预防CPSP的发展。氯胺酮术后持久止痛(KALPAS)是一项3期、多中心、随机、安慰剂对照的双盲试验，旨在研究氯胺酮降低PMPS的效果。这项研究比较了持续输注氯胺酮与单剂量氯胺酮在麻醉后护理单元与安慰剂在降低PMPS方面的作用。术后对参与者进行为期一年的跟踪观察。主要结果是在指数手术后3个月时手术部位的疼痛，用简明疼痛清单-简明疼痛严重程度子量表进行评估。该项目是美国国立卫生研究院帮助结束成瘾长期(Hear)倡议的一部分，该倡议是一项全国性的努力，旨在解决阿片类药物公共卫生危机。这项研究可以对围手术期疼痛管理产生重大影响，并对抗击阿片类药物流行做出重大贡献。临床试验.gov NCT05037123。注册日期为2021年9月8日。网上版载有补充材料，可在10.1186/s13063-023-07884-y查阅。
Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25–60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance with adjuvant therapy. Importantly, it is associated with chronic opioid use, as a recent study showed that 1 in 10 patients continue to use opioids at least 3 months after curative surgery. The majority of PMPS patients are women, and, over the past 10 years, women have outpaced men in the rate of growth in opioid dependence. Standard perioperative multimodal analgesia is only modestly effective in prevention of CPSP. Thus, interventions to reduce CPSP and PMPS are urgently needed. Ketamine is well known to improve pain and reduce opioid use in the acute postoperative period. Additionally, ketamine has been shown to control mood in studies of anxiety and depression. By targeting acute pain and improving mood in the perioperative period, ketamine may be able to prevent the development of CPSP. Ketamine analgesia for long-lasting pain relief after surgery (KALPAS) is a phase 3, multicenter, randomized, placebo-controlled, double-blind trial to study the effectiveness of ketamine in reducing PMPS. The study compares continuous perioperative ketamine infusion vs single-dose ketamine in the postanesthesia care unit vs placebo for reducing PMPS. Participants are followed for 1 year after surgery. The primary outcome is pain at the surgical site at 3 months after the index surgery as assessed with the Brief Pain Inventory-short form pain severity subscale. This project is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, a nationwide effort to address the opioid public health crisis. This study can substantially impact perioperative pain management and can contribute significantly to combatting the opioid epidemic. ClinicalTrials.gov NCT05037123. Registered on September 8, 2021. The online version contains supplementary material available at 10.1186/s13063-023-07884-y.
登录
查看更多内容
影响因子：
64.8
作者：
Autry, Anita E.;Adachi, Megunai;Nosyreva, Elena;Na, Elisa S.;Los, Maarten F.;Cheng, Peng-fei;Kavalali, Ege T.;Monteggia, Lisa M.
通讯作者：
Monteggia, Lisa M.
影响因子：
2.2
作者：
Laska E;Siegel C;Lin Z
通讯作者：
Lin Z
影响因子：
4.8
作者：
Chourbaji, S.;Vogt, M. A.;Gass, P.
通讯作者：
Gass, P.
影响因子：
9
作者：
Cron, David C.;Englesbe, Michael J.;Brummett, Chad M.
通讯作者：
Brummett, Chad M.
影响因子：
1.1
作者：
Faour, Mhamad;Anderson, Joshua T.;Ahn, Nicholas U.
通讯作者：
Ahn, Nicholas U.