Non-inferiority study assessing the utility of postcervical and lumbar radiofrequency ablation steroid use.

IF 5.1 2区 医学 Q1 ANESTHESIOLOGY
Mark R Williams, Annie Philip, Soun Sheen, Saumya Aujla, Changyong Feng, Shan Gao, Sarah Kralovic, Joseph Poli, Tammy Ortiz, Tatsiana Stefanos, Janet Pennella-Vaughan, Jennifer S Gewandter
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引用次数: 0

Abstract

Introduction: Many physicians administer steroids after radiofrequency ablation (RFA) to mitigate postprocedural inflammation and decrease postprocedural pain. However, robust evidence supporting the benefits of steroids after RFA is lacking and steroids have risks.

Methods: This study was a single-center, prospective, observational study designed to assess whether RFA alone is inferior to RFA with steroids for postprocedure pain. Eligible patients were at least 18 years of age and scheduled to undergo cervical or lumbar RFA. The primary outcome measure was the average pain score on the numeric rating scale (NRS) 7 days after the RFA. The secondary outcome measures included anxiety, depression and physical function, measured via the Patient-Reported Outcomes Measurement Information System short forms. All outcome measures were completed prior to the procedure and at 7 and 60 days postprocedure.

Results: Out of the 365 participants who completed baseline assessments, 175 received steroids and 190 did not receive steroids. The pain intensity at 7 days postprocedure was similar between the steroid and non-steroid groups (mean difference (steroid-non-steroid): -0.23). The 95% CI of the estimate (-0.76 to 0.30) was within the prespecified non-inferiority margin of 1.5 NRS points. Similar results were obtained for pain at 60 days (mean difference: 0.09; 95% CI -0.48 to 0.65). No significant differences between groups were observed for anxiety, depression or physical function at either 7 or 60 days.

Conclusion: This study suggests that the addition of steroids to the RFA procedure does not provide added benefits and is therefore not worth the additional risks that they pose.

评估颈椎和腰椎射频消融术后类固醇使用效用的非劣效性研究。
简介:许多医生在射频消融术(RFA)后使用类固醇,以减轻术后炎症和术后疼痛。然而,目前尚缺乏有力的证据支持射频消融术后使用类固醇类药物的益处,而且类固醇类药物也存在风险:本研究是一项单中心、前瞻性、观察性研究,旨在评估在治疗术后疼痛方面,单纯射频消融术是否不如射频消融术联合类固醇治疗。符合条件的患者至少年满18岁,并计划接受颈椎或腰椎RFA手术。主要结果指标是RFA术后7天数字评分量表(NRS)上的平均疼痛评分。次要结果测量包括焦虑、抑郁和身体功能,通过患者报告结果测量信息系统简表进行测量。所有结果测量均在手术前、手术后 7 天和 60 天完成:在完成基线评估的 365 名参与者中,175 人接受了类固醇治疗,190 人未接受类固醇治疗。类固醇组和非类固醇组在术后 7 天的疼痛强度相似(平均差异(类固醇-非类固醇)-0.23):-0.23).估计值的 95% CI(-0.76 至 0.30)在预设的 1.5 个 NRS 点的非劣效性范围内。60 天后的疼痛情况也得到了类似的结果(平均差异:0.09;95% CI -0.48-0.65)。在7天或60天时,各组在焦虑、抑郁或身体功能方面均无明显差异:这项研究表明,在射频消融术中添加类固醇并不会带来更多益处,因此不值得冒额外的风险。
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来源期刊
CiteScore
8.50
自引率
11.80%
发文量
175
审稿时长
6-12 weeks
期刊介绍: Regional Anesthesia & Pain Medicine, the official publication of the American Society of Regional Anesthesia and Pain Medicine (ASRA), is a monthly journal that publishes peer-reviewed scientific and clinical studies to advance the understanding and clinical application of regional techniques for surgical anesthesia and postoperative analgesia. Coverage includes intraoperative regional techniques, perioperative pain, chronic pain, obstetric anesthesia, pediatric anesthesia, outcome studies, and complications. Published for over thirty years, this respected journal also serves as the official publication of the European Society of Regional Anaesthesia and Pain Therapy (ESRA), the Asian and Oceanic Society of Regional Anesthesia (AOSRA), the Latin American Society of Regional Anesthesia (LASRA), the African Society for Regional Anesthesia (AFSRA), and the Academy of Regional Anaesthesia of India (AORA).
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