Efficacy and safety of PCA-assisted continuous paravertebral block in subacute herpes zoster-associated pain: study protocol for a randomized, controlled, double-blind superiority trial

PCA辅助下持续椎旁阻滞治疗亚急性带状疱疹相关疼痛的疗效和安全性:一项随机、对照、双盲优效性试验的研究方案

阅读:1

Abstract

BACKGROUND: Pain management for herpes zoster-associated pain (ZAP) is essential to improve patients' daily lives and potentially intervene in the chronicity. Long-lasting, repetitive painful stimuli might lead to central sensitization and neuropathic pain generation. The subacute phase is the main period for ZAP patients to seek medical attention, and it is also a critical treatment time window for the transformation of ZAP to chronic pathological changes. Although there is still a lack of rigorous considerable sample evidence, the pain degree of ZAP and the incidence of postherpetic neuralgia (PHN) may decrease accordingly with increasing adequate analgesia. Compared to repeated paravertebral nerve block (PVB), patient-controlled analgesia (PCA)-assisted continuous PVB provides more prolonged and comprehensive pain relief according to patient needs. Given this, we intend to test the hypothesis that PCA-assisted continuous PVB delivers a safe and better analgesic effect and reduces PHN incidence in subacute ZAP patients. METHODS: A total of 82 eligible subacute herpes zoster (SHZ) patients will be recruited and randomly assigned to the PCA-assisted continuous PVB group (Group PCA) and the repeated PVB group (Group rPVB) at a 1:1 ratio. All enrolled patients will undergo thoracic paravertebral space (TPVS) catheterization and receive similar doses of medication for 7 days. The main intervention factor lies in the different drug administration manners. PCA-assisted continuous PVB treatment will be achieved by pumping, while repeated PVB treatment will be conducted by injecting other therapeutic solutions. The participants and investigators will be both blinded to group allocation. The primary outcome is the VAS scores 1 month after treatment. The secondary outcomes include the incidence of PHN and the adverse events during treatment and follow-up. DISCUSSION: The results from this study will provide clinical evidence on the efficacy and safety of PCA-assisted continuous PVB for subacute ZAP patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300068158. Registered on 9 February 2023.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。