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Spread of injectate in pericapsular nerve group block: a Rashomon effect? 帽周神经组阻滞注射剂的扩散:罗生门效应?
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-05 DOI: 10.1136/rapm-2024-105870
Laura Girón-Arango, Philip Peng
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引用次数: 0
Anatomical evaluation of the superficial parasternal intercostal plane block. 胸骨旁肋间浅层阻滞的解剖学评估。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-05 DOI: 10.1136/rapm-2024-105818
Monica Harbell, James A Nelson, Natalie R Langley, David P Seamans, Ryan Craner

Background and objectives: Few cadaveric studies have evaluated the dye spread with superficial parasternal intercostal plane (SPIP) blocks. In this study, we examined the dye spread of an ultrasound-guided SPIP block in a human cadaveric model with single and double injection techniques.

Methods: Seven single and four double ultrasound-guided SPIP blocks were performed in seven unembalmed human cadavers using an in-plane approach with the transducer oriented parasagitally 1 cm lateral to the sternum. For the single SPIP, 20 mL of 0.166% methylene blue was injected in the second or third intercostal space into the plane between the Pec major muscle and internal intercostal muscles. For the double SPIP, 10 mL of 0.166% methylene blue was injected in the SPIP at one intercostal space with an additional 10 mL injected in the SPIP two intercostal spaces caudally. The extent of dye spread was documented.

Results: For all SPIP injections, there was consistent mediolateral spread from the sternum to the mid-clavicular line, with many extending laterally to the anterior axillary line. There was craniocaudal spread to a median of 2 intercostal muscles with a single SPIP and 3 intercostal muscles with a double SPIP. There was a median spread to 1 intercostal nerve for the single SPIP and 1.5 intercostal nerves with the double SPIP.

Conclusions: The SPIP block demonstrated limited spread in this cadaver study. A single injection of this block may be of limited value and multiple SPIP injections may be needed to have adequate spread for anterior thoracic procedures.

背景和目的:很少有尸体研究对胸骨旁肋间浅层(SPIP)阻滞的染料扩散进行评估。在这项研究中,我们在人体模型中采用单次和两次注射技术,检查了超声引导下 SPIP 阻滞的染料扩散情况:方法:我们在七具未失去知觉的人体尸体上进行了七次单次和四次双次超声引导下的 SPIP 阻滞,采用的是平面内方法,换能器的方向在胸骨外侧 1 厘米处。进行单SPIP时,在第二或第三肋间隙向胸大肌和肋间内肌之间的平面注射20毫升0.166%亚甲蓝。对于双SPIP,在SPIP的一个肋间隙注入10毫升0.166%亚甲蓝,再在SPIP向后两个肋间隙注入10毫升。记录染料扩散的范围:结果:在所有 SPIP 注射中,从胸骨到锁骨中线都有一致的内外侧扩散,许多扩散到了腋窝前线。单次 SPIP 的颅尾扩散中位数为 2 个肋间肌,双次 SPIP 的颅尾扩散中位数为 3 个肋间肌。单SPIP阻滞的中线扩散至1条肋间神经,双SPIP阻滞的中线扩散至1.5条肋间神经:结论:在这项尸体研究中,SPIP阻滞的扩散范围有限。结论:在这项尸体研究中,SPIP 阻滞的扩散范围有限,单次注射这种阻滞的价值可能有限,可能需要多次 SPIP 注射才能在胸腔前部手术中获得足够的扩散。
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引用次数: 0
Long-term explantation risk in patients with chronic pain treated with spinal cord or dorsal root ganglion stimulation. 接受脊髓或背根神经节刺激治疗的慢性疼痛患者的长期切除风险。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-05 DOI: 10.1136/rapm-2024-105719
Kliment Gatzinsky, Beatrice Brink, Kristin Lilja Eyglóardóttir, Tobias Hallén

Objective: To investigate long-term explantation risks and causes for the explantation of neuromodulation devices for the treatment of chronic pain from different manufacturers.

Methods: This retrospective analysis included patients implanted with a system for spinal cord stimulation (SCS) or dorsal root ganglion (DRG) stimulation at Sahlgrenska University Hospital between January 2012 and December 2022. Patient characteristics, explantation rates and causes for explantation were obtained by reviewing medical records.

Results: In total, 400 patients were included in the study. Including all manufacturers, the cumulative explantation risk for any reason was 17%, 23% and 38% at 3, 5 and 10 years, respectively. Explantation risk due to diminished pain relief at the same intervals was 10%, 14% and 23%. A subgroup comparison of 5-year explantation risk using Kaplan-Meier analysis did not show a statistically significant difference between the manufacturers. In multivariable Cox regression analyses, there was no difference in explantation risk for any reason, but for explantation due to diminished pain relief, a higher risk was noted for Medtronic (preferably older types of SCS devices) and DRG stimulation. No other predictive factor for explantation was found.

Conclusions: Although SCS and DRG stimulation are well-established and safe treatments for chronic pain, the long-term explantation risk remains high. The difference between manufacturers highlights the importance of technological evolution for improving therapy outcomes. Increased stringency in patient selection and follow-up strategies, as well as further development of device hardware and software technology for increased longevity, could possibly reduce long-term explantation risks.

目的调查不同制造商生产的用于治疗慢性疼痛的神经调控装置的长期更换风险和更换原因:这项回顾性分析包括2012年1月至2022年12月期间在瑞典萨赫格伦斯卡大学医院植入脊髓刺激(SCS)或背根神经节(DRG)刺激系统的患者。研究人员通过查阅病历获得了患者特征、切除率和切除原因:研究共纳入 400 名患者。包括所有制造商在内,3年、5年和10年后,因任何原因导致的累计置换风险分别为17%、23%和38%。在相同的时间间隔内,因疼痛缓解程度降低而导致的置换风险分别为 10%、14% 和 23%。使用 Kaplan-Meier 分析法对 5 年拆卸风险进行分组比较后发现,不同制造商之间的差异并不显著。在多变量 Cox 回归分析中,任何原因导致的切除风险均无差异,但对于因疼痛缓解程度降低而导致的切除,美敦力(最好是较老类型的 SCS 装置)和 DRG 刺激的风险较高。未发现其他可预测手术切除的因素:结论:尽管 SCS 和 DRG 刺激是治疗慢性疼痛的行之有效的安全疗法,但长期拆机风险仍然很高。制造商之间的差异凸显了技术革新对改善治疗效果的重要性。提高患者选择和随访策略的严格程度,以及进一步开发设备硬件和软件技术以延长使用寿命,都有可能降低长期拆机风险。
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引用次数: 0
Criteria for continuous neuraxial analgesia associated with reduced mortality in patients undergoing thoracotomy. 与降低胸廓切开术患者死亡率相关的持续神经镇痛标准。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-05 DOI: 10.1136/rapm-2024-105537
Axel Semmelmann, Wolfgang Baar, Isabelle Moneke, Torsten Loop

Introduction: Both thoracic epidural analgesia and thoracic paravertebral analgesia are effective techniques to control pain and minimize the stress response following thoracic surgery. We hypothesized that continuous neuraxial techniques may be associated with a decrease in the incidence of postoperative mortality after thoracotomy. Additionally, we aimed to identify subgroup populations that may benefit more from neuraxial anesthesia.

Method: 1620 patients who underwent open thoracotomy were included in this retrospective study from the German Thoracic Registry database at four university hospitals. All-cause inpatient mortality was determined for patients who had and did not have neuraxial anesthesia. Logistic regression was used to adjust for and explore various covariates.

Results: Continuous neuraxial analgesia was associated with a lower overall mortality in the postoperative period (2.9%, 23/796 vs 5.3%, 44/824, p=0.02) only after the univariate analysis but not the multivariable analysis (OR 0.49, 95 % CI 0.237 to 1.12, p=0.15). In patients with epidural or paravertebral catheters, mortality was significantly lower in the following subgroups: age >75 (5/113 vs 18/77, OR 0.1, 95% CI 0.02 to 0.67, p=0.02), American Society of Anesthesiologists Performance Score >III (11//97 vs 33/155, OR 0.32, 95% CI 0.11 to 0.89, p=0.03), chronic kidney disease (5/83 vs 16/77, OR 0.16, 95% CI 0.03 to 0.82, p=0.03), and postoperative sepsis (9/21 vs 17/25, OR 0.13, 95% CI 0.07 to 0.44, p<0.01).

Conclusions: Neuraxial analgesic techniques are associated with reductions in postoperative mortality after open thoracic surgery in selected patients.

导言:胸腔硬膜外镇痛和胸椎旁镇痛都是控制疼痛和减少胸腔手术后应激反应的有效技术。我们假设连续神经轴技术可能与胸廓切开术后死亡率的降低有关。此外,我们还旨在确定可能从神经麻醉中获益更多的亚组人群:这项回顾性研究从四家大学医院的德国胸腔登记数据库中纳入了 1620 名接受开胸手术的患者。对进行和未进行神经麻醉的患者的全因住院死亡率进行了测定。采用逻辑回归对各种协变量进行了调整和探讨:经过单变量分析,连续神经轴镇痛与较低的术后总死亡率相关(2.9%,23/796 vs 5.3%,44/824,p=0.02),但与多变量分析无关(OR 0.49,95 % CI 0.237 to 1.12,p=0.15)。在使用硬膜外或椎旁导管的患者中,以下亚组的死亡率明显较低:年龄大于 75 岁(5/113 vs 18/77,OR 0.1,95% CI 0.02 至 0.67,P=0.02)、美国麻醉医师协会表现评分大于 III(11/97 vs 33/155,OR 0.32, 95% CI 0.11 to 0.89, p=0.03)、慢性肾病(5/83 vs 16/77,OR 0.16, 95% CI 0.03 to 0.82, p=0.03)和术后败血症(9/21 vs 17/25,OR 0.13, 95% CI 0.07 to 0.44, p结论:神经轴镇痛技术可降低特定患者开胸手术后的死亡率。
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引用次数: 0
Global estimates of prevalence of chronic painful neuropathy and moderate-to-severe neuropathy among patients with chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis of data from 29 countries between 2000 and 2024. 化疗引起的周围神经病变患者慢性疼痛性神经病变的全球患病率估计:来自28个国家2000-24年数据的系统回顾和荟萃分析。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-04 DOI: 10.1136/rapm-2024-106229
Ryan S D'Souza, Chandan Saini, Nasir Hussain, Saba Javed, Larry Prokop, Yeng F Her

Introduction: Although the prevalence of chemotherapy-induced peripheral neuropathy (CIPN) has been reported, the proportion of patients with CIPN who report chronic moderate-to-severe neuropathy or chronic painful neuropathy remains poorly understood, despite its significant impact on patients' quality of life and treatment outcomes.

Methods: A systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The primary outcome was the pooled prevalence of chronic (≥3 months) moderate-to-severe CIPN or painful CIPN among patients diagnosed with CIPN. Estimates from each study were transformed using a double-arcsine transformation and pooled in a meta-analysis using an inverse variance heterogeneity model. Subgroup analysis was conducted based on geographical region, sex, chemotherapy regimen, primary cancer type, and funding source; metaregression analysis was conducted based on study design, human development index (HDI), and publication year.

Results: 76 studies from 29 countries, encompassing 13 635 patients with CIPN, were included. Among patients diagnosed with CIPN, the pooled prevalence of those reporting chronic moderate-to-severe CIPN or painful CIPN was estimated at 47.76% (95% CI 37.50 to 58.08; 95% prediction interval 24.68-71.84). Substantial heterogeneity was observed across studies (=97.45%; 95% CI for I 2 97.15 to 97.72). Subgroup analysis revealed that patients treated with platinum-based agents and taxanes had the highest prevalence of chronic moderate-to-severe CIPN or painful CIPN (44.47% and 55.68%, respectively), and among primary cancers, those with breast cancer, multiple myeloma, and lung cancer reported the highest prevalence of chronic moderate-to-severe CIPN or painful CIPN (61.31%, 53.55%, and 50.85%, respectively). Study design, HDI, and publication year were non-significant moderators of prevalence estimates. Based on our Grading of Recommendations, Assessment, Development, and Evaluation assessment, the certainty of evidence was considered "very low." Sensitivity analysis restricted to studies explicitly measuring painful CIPN (40.78%; 95% CI 29.08 to 52.74) or moderate-to-severe CIPN (49.04%; 95% CI 37.16 to 60.95) yielded similar prevalence estimates.

Conclusion: This study provides the first comprehensive global estimate of the prevalence of chronic moderate-to-severe CIPN or painful CIPN, highlighting its significant burden on patients worldwide. The variation in prevalence across geographical regions, chemotherapy regimens, and primary cancers underscores the need for tailored management strategies and further research to address potential disparities.

导论:尽管化疗诱导的周围神经病变(CIPN)的患病率已经有报道,但CIPN患者报告慢性疼痛性神经病变的比例仍然知之甚少,尽管它对患者的生活质量和治疗结果有重大影响。方法:按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行系统评价和荟萃分析。主要结局是诊断为CIPN的患者中慢性(≥3个月)疼痛性CIPN的总患病率。使用双反正弦变换对每项研究的估价值进行转换,并使用逆方差异质性模型将其合并到荟萃分析中。根据地理区域、性别、化疗方案、原发肿瘤类型和资金来源进行亚组分析;根据研究设计、人类发展指数(HDI)和出版年份进行meta回归分析。结果:来自28个国家的77项研究纳入了10962例CIPN患者。在诊断为CIPN的患者中,报告慢性疼痛性CIPN的总患病率估计为41.22% (95% CI 32.40至50.19;95%预测区间23.71 ~ 61.28)。研究间存在显著异质性(I²=95.27%;95% CI为94.58 ~ 95.86)。亚组分析显示,接受铂类药物和紫杉烷类药物治疗的患者慢性疼痛性CIPN患病率最高(分别为40.44%和38.35%),而在原发癌症中,肺癌患者慢性疼痛性CIPN患病率最高(60.26%)。研究设计、人类发展指数和出版年份是患病率估计的非显著调节因子。根据我们的GRADE(推荐、评估、发展和评价分级)评估,证据的确定性被认为非常低。结论:本研究首次全面评估了慢性疼痛性CIPN的全球患病率,强调了其对全球患者的重大负担。不同地理区域、化疗方案和原发癌症的患病率差异强调了定制疼痛管理策略和进一步研究以解决潜在差异的必要性。试验注册:PROSPERO CRD42024579459。
{"title":"Global estimates of prevalence of chronic painful neuropathy and moderate-to-severe neuropathy among patients with chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis of data from 29 countries between 2000 and 2024.","authors":"Ryan S D'Souza, Chandan Saini, Nasir Hussain, Saba Javed, Larry Prokop, Yeng F Her","doi":"10.1136/rapm-2024-106229","DOIUrl":"10.1136/rapm-2024-106229","url":null,"abstract":"<p><strong>Introduction: </strong>Although the prevalence of chemotherapy-induced peripheral neuropathy (CIPN) has been reported, the proportion of patients with CIPN who report chronic moderate-to-severe neuropathy or chronic painful neuropathy remains poorly understood, despite its significant impact on patients' quality of life and treatment outcomes.</p><p><strong>Methods: </strong>A systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The primary outcome was the pooled prevalence of chronic (≥3 months) moderate-to-severe CIPN or painful CIPN among patients diagnosed with CIPN. Estimates from each study were transformed using a double-arcsine transformation and pooled in a meta-analysis using an inverse variance heterogeneity model. Subgroup analysis was conducted based on geographical region, sex, chemotherapy regimen, primary cancer type, and funding source; metaregression analysis was conducted based on study design, human development index (HDI), and publication year.</p><p><strong>Results: </strong>76 studies from 29 countries, encompassing 13 635 patients with CIPN, were included. Among patients diagnosed with CIPN, the pooled prevalence of those reporting chronic moderate-to-severe CIPN or painful CIPN was estimated at 47.76% (95% CI 37.50 to 58.08; 95% prediction interval 24.68-71.84). Substantial heterogeneity was observed across studies (<i>I²</i>=97.45%; 95% CI for <i>I</i> <sup>2</sup> 97.15 to 97.72). Subgroup analysis revealed that patients treated with platinum-based agents and taxanes had the highest prevalence of chronic moderate-to-severe CIPN or painful CIPN (44.47% and 55.68%, respectively), and among primary cancers, those with breast cancer, multiple myeloma, and lung cancer reported the highest prevalence of chronic moderate-to-severe CIPN or painful CIPN (61.31%, 53.55%, and 50.85%, respectively). Study design, HDI, and publication year were non-significant moderators of prevalence estimates. Based on our Grading of Recommendations, Assessment, Development, and Evaluation assessment, the certainty of evidence was considered \"very low.\" Sensitivity analysis restricted to studies explicitly measuring painful CIPN (40.78%; 95% CI 29.08 to 52.74) or moderate-to-severe CIPN (49.04%; 95% CI 37.16 to 60.95) yielded similar prevalence estimates.</p><p><strong>Conclusion: </strong>This study provides the first comprehensive global estimate of the prevalence of chronic moderate-to-severe CIPN or painful CIPN, highlighting its significant burden on patients worldwide. The variation in prevalence across geographical regions, chemotherapy regimens, and primary cancers underscores the need for tailored management strategies and further research to address potential disparities.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intrathecal adjuvants. 囊内的佐剂。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-04 DOI: 10.1136/rapm-2025-106713
Reginald Edward
{"title":"Intrathecal adjuvants.","authors":"Reginald Edward","doi":"10.1136/rapm-2025-106713","DOIUrl":"https://doi.org/10.1136/rapm-2025-106713","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145679541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response to: Intrathecal adjuvants. 反应:鞘内佐剂。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-04 DOI: 10.1136/rapm-2025-106810
Martina Ollosu, Vincenzo Francesco Tripodi, Alessandro Bonu, Guglielmo Cittadini, Mario Musu, Mariachiara Ippolito, Andrea Cortegiani, Gabriele Finco, Salvatore Sardo
{"title":"Response to: Intrathecal adjuvants.","authors":"Martina Ollosu, Vincenzo Francesco Tripodi, Alessandro Bonu, Guglielmo Cittadini, Mario Musu, Mariachiara Ippolito, Andrea Cortegiani, Gabriele Finco, Salvatore Sardo","doi":"10.1136/rapm-2025-106810","DOIUrl":"https://doi.org/10.1136/rapm-2025-106810","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145679562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of removing liposomal bupivacaine from a health system formulary on length of stay: an observational study in video-assisted thoracoscopic wedge resection. 从卫生系统处方中去除布比卡因脂质体对住院时间的影响:视频辅助胸腔镜楔形切除术的观察性研究。
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-04 DOI: 10.1136/rapm-2025-107239
Anuj B Patel, Gerard J Kerins, Brian D Sites, Timothy M Millington, Yvon Bryan, Matthew Davis
{"title":"Impact of removing liposomal bupivacaine from a health system formulary on length of stay: an observational study in video-assisted thoracoscopic wedge resection.","authors":"Anuj B Patel, Gerard J Kerins, Brian D Sites, Timothy M Millington, Yvon Bryan, Matthew Davis","doi":"10.1136/rapm-2025-107239","DOIUrl":"https://doi.org/10.1136/rapm-2025-107239","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145679531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Growing market for pain-related medical devices: what anesthesia and pain providers can learn from the Open Payments Database. 与疼痛相关的医疗设备的增长市场:麻醉和疼痛提供者可以从开放支付数据库中学到什么?
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-04 DOI: 10.1136/rapm-2025-107422
Julia Isabella Klein, Mishan D Rambukwella, Kathy S Cazares, Tristan Grogan, Dane A Saksa
{"title":"Growing market for pain-related medical devices: what anesthesia and pain providers can learn from the Open Payments Database.","authors":"Julia Isabella Klein, Mishan D Rambukwella, Kathy S Cazares, Tristan Grogan, Dane A Saksa","doi":"10.1136/rapm-2025-107422","DOIUrl":"https://doi.org/10.1136/rapm-2025-107422","url":null,"abstract":"","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145679454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical utility of ECAP dosing in a real-world population delivered via EVOKE therapy: the ECAP study. ECAP给药在现实世界人群中的临床应用:ECAP研究
IF 3.5 2区 医学 Q1 ANESTHESIOLOGY Pub Date : 2025-12-01 DOI: 10.1136/rapm-2025-107051
Jason E Pope, Gregory L Smith, Johnathan A Goree, Nagy A Mekhail, Robert M Levy, Timothy R Deer, Chau M Vu, Jarna Shah, Shrif J Costandi, Steven M Rosen, Todd A Bromberg, Atish Patel, Dawood Sayed, Christopher M Lam, Usman Latif, Shivanand P Lad, Jessica B Jameson, Aaron K Calodney, Steven M Falowski, Jack Smith, Salim M Hayek, Maged Guirguis, Ronald B Boeding, Jonathan M Hagedorn, Michael Sprintz, Ajay Antony, Denis Patterson, Robert D Heros, Andras Laufer, Julie G Pilitsis, Nathan Miller, David Rosenfeld, Jordan L Tate, Ahmed M Raslan, Jan Willem Kallewaard, Angela Leitner, Erin Hanson, Nicole Soliday, Rui V Duarte, Erika A Petersen

Background: The efficacy of EVOKE therapy, a closed-loop spinal cord stimulation (SCS) system, has been demonstrated in a double-blinded randomized controlled trial (RCT). RCT evidence, however, may not be generalizable to clinical practice, while limitations of real-world evidence may affect its validity. The aim of this study was to evaluate the effectiveness of EVOKE therapy in routine clinical practice employing a rigorous data collection approach.

Methods: The ECAP study was a prospective, multicenter, single-arm, pragmatic study that enrolled SCS candidates with chronic, intractable trunk and/or limb pain in 22 US investigational sites. PROMIS-29 questionnaire and objective neurophysiological metrics were collected, and minimal clinically important differences (MCIDs) were used to characterize baseline dysfunction and response to EVOKE therapy both at trial end and maximal analgesic effect post-implant visit. Pre-specified subgroup analyses were conducted based on diagnosis.

Results: EVOKE therapy observed included a dose ratio of 1.3 and neural dose accuracy of 2.8 μV. Improvements of >1 MCID were observed for all domains and improvements of ≥2 MCIDs were observed for six of the seven domains. Improvements observed at trial end were maintained or improved at post-implant visit, with statistically significant improvement in holistic MCID (MD 0.2, 95% CI 0.1 to 0.4, p=0.004), and a significantly greater proportion of patients considered holistic MCID responders (p=0.047). Subgroup analysis by diagnosis showed similar outcomes.

Conclusions: EVOKE therapy was associated with clinically meaningful improvements in a real-world chronic pain population across different subgroups and disease pathologies, with effects observed at trial end reproduced at post-implant visit.

背景:一项双盲随机对照试验(RCT)已经证实了一种闭环脊髓刺激(SCS)系统——EVOKE疗法的疗效。然而,随机对照试验证据可能不能推广到临床实践,而现实世界证据的局限性可能会影响其有效性。本研究的目的是通过严格的数据收集方法来评估EVOKE疗法在常规临床实践中的有效性。方法:ECAP研究是一项前瞻性、多中心、单臂、实用的研究,在美国22个研究地点招募了患有慢性、难治性躯干和/或肢体疼痛的SCS患者。收集promise -29问卷和客观神经生理指标,并使用最小临床重要差异(MCIDs)来表征试验结束时基线功能障碍和对EVOKE治疗的反应,以及植入物访问后的最大镇痛效果。根据诊断进行预先指定的亚组分析。结果:观察到的EVOKE疗法的剂量比为1.3,神经剂量准确度为2.8 μV。在所有领域中,bbbb1型MCID均有改善,在7个领域中,有6个领域的MCID≥2型均有改善。在试验结束时观察到的改善在种植体后随访时保持或改善,整体MCID的改善具有统计学意义(MD 0.2, 95% CI 0.1至0.4,p=0.004),并且整体MCID应答的患者比例显着增加(p=0.047)。诊断亚组分析结果相似。结论:在现实世界中,不同亚组和疾病病理的慢性疼痛人群中,EVOKE疗法与临床有意义的改善相关,在试验结束时观察到的效果在植入物后随访时重现。
{"title":"Clinical utility of ECAP dosing in a real-world population delivered via EVOKE therapy: the ECAP study.","authors":"Jason E Pope, Gregory L Smith, Johnathan A Goree, Nagy A Mekhail, Robert M Levy, Timothy R Deer, Chau M Vu, Jarna Shah, Shrif J Costandi, Steven M Rosen, Todd A Bromberg, Atish Patel, Dawood Sayed, Christopher M Lam, Usman Latif, Shivanand P Lad, Jessica B Jameson, Aaron K Calodney, Steven M Falowski, Jack Smith, Salim M Hayek, Maged Guirguis, Ronald B Boeding, Jonathan M Hagedorn, Michael Sprintz, Ajay Antony, Denis Patterson, Robert D Heros, Andras Laufer, Julie G Pilitsis, Nathan Miller, David Rosenfeld, Jordan L Tate, Ahmed M Raslan, Jan Willem Kallewaard, Angela Leitner, Erin Hanson, Nicole Soliday, Rui V Duarte, Erika A Petersen","doi":"10.1136/rapm-2025-107051","DOIUrl":"https://doi.org/10.1136/rapm-2025-107051","url":null,"abstract":"<p><strong>Background: </strong>The efficacy of EVOKE therapy, a closed-loop spinal cord stimulation (SCS) system, has been demonstrated in a double-blinded randomized controlled trial (RCT). RCT evidence, however, may not be generalizable to clinical practice, while limitations of real-world evidence may affect its validity. The aim of this study was to evaluate the effectiveness of EVOKE therapy in routine clinical practice employing a rigorous data collection approach.</p><p><strong>Methods: </strong>The ECAP study was a prospective, multicenter, single-arm, pragmatic study that enrolled SCS candidates with chronic, intractable trunk and/or limb pain in 22 US investigational sites. PROMIS-29 questionnaire and objective neurophysiological metrics were collected, and minimal clinically important differences (MCIDs) were used to characterize baseline dysfunction and response to EVOKE therapy both at trial end and maximal analgesic effect post-implant visit. Pre-specified subgroup analyses were conducted based on diagnosis.</p><p><strong>Results: </strong>EVOKE therapy observed included a dose ratio of 1.3 and neural dose accuracy of 2.8 μV. Improvements of >1 MCID were observed for all domains and improvements of ≥2 MCIDs were observed for six of the seven domains. Improvements observed at trial end were maintained or improved at post-implant visit, with statistically significant improvement in holistic MCID (MD 0.2, 95% CI 0.1 to 0.4, p=0.004), and a significantly greater proportion of patients considered holistic MCID responders (p=0.047). Subgroup analysis by diagnosis showed similar outcomes.</p><p><strong>Conclusions: </strong>EVOKE therapy was associated with clinically meaningful improvements in a real-world chronic pain population across different subgroups and disease pathologies, with effects observed at trial end reproduced at post-implant visit.</p>","PeriodicalId":54503,"journal":{"name":"Regional Anesthesia and Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145662676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Regional Anesthesia and Pain Medicine
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