背景:腰椎内侧支传导阻滞(MBB)是美国一些最常见的疼痛手术。进行诊断MBB以确认下腰痛的发生器是否是小关节。然而,诊断注射,可能会出现假阳性块。
目的:我们的前瞻性观察性研究旨在研究咪达唑仑镇静对腰椎MBB术后患者感觉疼痛缓解强度的影响。
方法:这是一项在clinicaltrials.gov(NCT04453449)注册的单中心多地点前瞻性观察研究。
方法:该研究于2020年6月获得亨利·福特卫生系统机构审查委员会(IRB#14010)的批准,并于2020年7月在clinicaltrials.gov上注册(NCT04453449)。本手稿遵循适用于观察性队列研究的EQUATORSTROBE指南。
方法:将接受MBB治疗但没有镇静的患者与镇静的患者进行比较。患者被要求在基线时完成数字评定量表(NRS),在他们的诊断障碍后的一天,以及腰椎射频消融(RFA)后4周和8周。主要结果是基线NRS疼痛评分与MBB后8小时内最低报告评分之间的差异。对于进行RFA的患者,评估了假阳性阻断的频率.当患者在2个成功的序贯MBB后未能从RFA中获得50%的疼痛缓解时,认为患者具有假阳性阻滞。
结果:在诊断性区块1(P=0.167)和诊断性区块2(P=0.6145)中,镇静组与非镇静组的NRS疼痛评分变化无显著差异。在RFA后4周(P=0.7178)和RFA后8周(P=1.000),非镇静和镇静患者的假阳性率没有显着差异。
结论:这项研究的一些局限性包括其非随机设计,患者自我报告疼痛评分,以及程序学家的注射技术和注射部位的解剖位置的微小变异性。
结论:这项研究表明,咪达唑仑并未改变MBB后患者的疼痛感觉强度,以及RFA后的假阳性率。需要更大规模的研究才能得出明确的结论。
BACKGROUND: Lumbar medial branch blocks (MBB) are some of the most commonly performed pain procedures in the United States. Diagnostic MBBs are performed to confirm if the generator of low back pain is the facet joint. However, with diagnostic injections, false positive blocks may occur.
OBJECTIVE: Our prospective observational
study aims to investigate the effects of midazolam sedation on patients\' perceived intensity of pain relief following lumbar MBB.
METHODS: This is a single-center multi-site prospective observational
study registered on clinicaltrials.gov (NCT04453449).
METHODS: The
study was approved by the Henry Ford Health System Institutional Review Board (IRB) in June 2020 (IRB# 14010) and registered on clinicaltrials.gov in July 2020 (NCT04453449). This manuscript adheres to the applicable EQUATOR STROBE guidelines for an observational cohort
study.
METHODS: Patients that underwent MBB without sedation were compared to sedated patients. Patients were asked to complete the Numeric Rating Scale (NRS) at baseline, one day after their diagnostic blocks, as well as 4 weeks and 8 weeks after their lumbar radiofrequency ablation (RFA). The primary outcome is the difference between baseline NRS pain scores and the lowest reported score in the 8 hours following MBB. For patients who proceed to RFA, the frequency of false positive blocks was evaluated. A patient was considered to have a false positive block when they failed to achieve 50% pain relief from RFA after 2 successful sequential MBBs.
RESULTS: There was no significant difference in the NRS pain score change between the sedated and non-sedated groups for diagnostic block one (P = 0.167) and diagnostic block 2 (P = 0.6145). There was no significant difference of false positive rates between non-sedation and sedation patients at 4-weeks post-RFA (P = 0.7178) and at 8-weeks post-RFA (P = 1.000).
CONCLUSIONS: Some of the limitations of this study include its nonrandomized design, patient self-reported pain scores, as well as the small variability in the injection technique of proceduralists and in the anatomical location of the injection site.
CONCLUSIONS: This
study showed that midazolam did not change patients\' perceived intensity of pain following MBB, as well as false positive rates after RFA. Larger studies are required to draw definitive conclusions.