Ziv Savin, Kavita Gupta, Eve Frangopoulos, Vinay Durbhakula, Asher Mandel, Christopher Connors, Anna Ricapito, Raymond Khargi, Alan J Yaghoubian, Blair Gallante, William M Atallah, Mantu Gupta
{"title":"非甾体类抗炎药作为阿片类药物安全有效替代经皮肾镜取石术后疼痛缓解的随机对照试验。","authors":"Ziv Savin, Kavita Gupta, Eve Frangopoulos, Vinay Durbhakula, Asher Mandel, Christopher Connors, Anna Ricapito, Raymond Khargi, Alan J Yaghoubian, Blair Gallante, William M Atallah, Mantu Gupta","doi":"10.1089/end.2025.0090","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Introduction:</i></b> This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized. <b><i>Methods:</i></b> After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1-5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary. <b><i>Results:</i></b> The cohort had median age of 65 years (interquartile range [IQR]: 49-70), stone burden of 975 mm³ (IQR: 558-2356), STONE score of 6 (IQR: 5-7), and operative time of 66 minutes (IQR: 53-90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1-5 were similar across both treatment groups (<i>p</i> = 0.18 and <i>p</i> = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 <i>vs</i> 12, <i>p</i> < 0.01). All other secondary outcomes were not different between the groups. <b><i>Conclusion:</i></b> NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.</p>","PeriodicalId":15723,"journal":{"name":"Journal of endourology","volume":" ","pages":"888-896"},"PeriodicalIF":2.8000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized Controlled Trial of Nonsteroidal Anti-Inflammatory Drugs as a Safe and Effective Alternative to Opioids for Pain Relief Following Percutaneous Nephrolithotomy.\",\"authors\":\"Ziv Savin, Kavita Gupta, Eve Frangopoulos, Vinay Durbhakula, Asher Mandel, Christopher Connors, Anna Ricapito, Raymond Khargi, Alan J Yaghoubian, Blair Gallante, William M Atallah, Mantu Gupta\",\"doi\":\"10.1089/end.2025.0090\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Introduction:</i></b> This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized. <b><i>Methods:</i></b> After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1-5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary. <b><i>Results:</i></b> The cohort had median age of 65 years (interquartile range [IQR]: 49-70), stone burden of 975 mm³ (IQR: 558-2356), STONE score of 6 (IQR: 5-7), and operative time of 66 minutes (IQR: 53-90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1-5 were similar across both treatment groups (<i>p</i> = 0.18 and <i>p</i> = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 <i>vs</i> 12, <i>p</i> < 0.01). All other secondary outcomes were not different between the groups. <b><i>Conclusion:</i></b> NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.</p>\",\"PeriodicalId\":15723,\"journal\":{\"name\":\"Journal of endourology\",\"volume\":\" \",\"pages\":\"888-896\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of endourology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/end.2025.0090\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of endourology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/end.2025.0090","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/7 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
简介:本随机对照试验旨在证明在阿片类药物普遍使用的时代,非甾体抗炎药(NSAIDs)与麻醉药相比,在经皮肾镜取石术(PCNL)术后疼痛管理方面的非劣效性。方法:经机构审查委员会批准,于2023年5月至2025年1月期间在我院计划进行PCNL的85例患者同意并随机接受羟考酮(OXY)或酮洛拉酸(KET)在家进行术后疼痛管理。纳入标准为单侧、单通道标准PCNL,而排除标准包括解剖异常、KET/OXY禁忌症、既往支架或肾造口管。主要观察指标为术后1-5天的视觉模拟评分(VAS)疼痛评分。次要结果记录在POD 10办公室访问中,包括VAS评分、患者报告的结果测量信息系统问卷、药片数量、因疼痛而打来的办公室电话和药物相关不良事件。并发症结果也被列为次要因素。结果:患者中位年龄65岁(四分位间距[IQR]: 49-70),结石负担975 mm³(IQR: 558-2356), stone评分6 (IQR: 5-7),手术时间66分钟(IQR: 53-90)。基线特征,包括临床、结石和术中变量,组间具有可比性。两个治疗组pod 1-5的最大和平均VAS疼痛评分相似(p = 0.18和p = 0.17)。OXY组患者在10天内服用的药片较少(中位数为6.5 vs 12, p < 0.01)。所有其他次要结果在两组之间没有差异。结论:与阿片类药物相比,非甾体抗炎药在PCNL术后提供了相当的疼痛缓解,副作用最小,使其成为无禁忌症患者的可行选择。我们的研究是这一主题的第一个一级证据。
Randomized Controlled Trial of Nonsteroidal Anti-Inflammatory Drugs as a Safe and Effective Alternative to Opioids for Pain Relief Following Percutaneous Nephrolithotomy.
Introduction: This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized. Methods: After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1-5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary. Results: The cohort had median age of 65 years (interquartile range [IQR]: 49-70), stone burden of 975 mm³ (IQR: 558-2356), STONE score of 6 (IQR: 5-7), and operative time of 66 minutes (IQR: 53-90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1-5 were similar across both treatment groups (p = 0.18 and p = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 vs 12, p < 0.01). All other secondary outcomes were not different between the groups. Conclusion: NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.
期刊介绍:
Journal of Endourology, JE Case Reports, and Videourology are the leading peer-reviewed journal, case reports publication, and innovative videojournal companion covering all aspects of minimally invasive urology research, applications, and clinical outcomes.
The leading journal of minimally invasive urology for over 30 years, Journal of Endourology is the essential publication for practicing surgeons who want to keep up with the latest surgical technologies in endoscopic, laparoscopic, robotic, and image-guided procedures as they apply to benign and malignant diseases of the genitourinary tract. This flagship journal includes the companion videojournal Videourology™ with every subscription. While Journal of Endourology remains focused on publishing rigorously peer reviewed articles, Videourology accepts original videos containing material that has not been reported elsewhere, except in the form of an abstract or a conference presentation.
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