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HYSPAIN临床试验:评估宫颈旁麻醉在门诊宫腔镜检查中控制疼痛的疗效:一项随机、单中心、双盲、安慰剂对照临床试验。

HYSPAIN CLINICAL TRIAL Testing the Efficacy of Paracervical Anesthesia for Pain Control During Office Hysteroscopy: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Clinical Trial.

作者信息

Adrien-Lara María, Pereira Augusto, Vitale Salvatore Giovanni, Ríos Mar, Pérez-Medina Tirso, Calles-Sastre Laura

机构信息

Gynaecology and Obstetrics Department, Hospital Universitario Puerta de Hierro, Majadahonda, 28222 Madrid, Spain.

Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, 09124 Cagliari, Italy.

出版信息

J Clin Med. 2024 Dec 23;13(24):7856. doi: 10.3390/jcm13247856.

DOI:10.3390/jcm13247856
PMID:39768779
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11728129/
Abstract

Hysteroscopy is a key gynecological procedure for diagnosing and treating endometrial conditions. While hysteroscopy is often performed in office settings without sedation, patients frequently report significant pain during the procedure. This study aims to evaluate the efficacy of paracervical anesthesia with mepivacaine compared to placebo in managing pain during office hysteroscopy. This randomized, single-center, double-blind, placebo-controlled trial was conducted at Puerta de Hierro University Hospital (Madrid, Spain) from June 2021 to June 2022. A total of 108 women were randomized to receive either mepivacaine 2% or a saline placebo prior to hysteroscopy. Pain was assessed using a visual analog scale (VAS) at various stages of the procedure. The results showed no significant differences in pain levels between the mepivacaine and placebo groups during the procedure. Both groups exhibited similar rates of complications and procedural difficulties. Factors influencing perceived pain included a history of vaginal delivery and the type of instruments used, but anesthesia did not demonstrate a significant impact on pain reduction in any subgroup. : Our findings indicate that paracervical anesthesia with mepivacaine does not significantly reduce pain during office hysteroscopy, consistent with previous studies. The variability in pain experiences suggests that individual factors, such as pain thresholds and anxiety, may play a significant role. A more personalized approach to pain management, combining pharmacological and non-pharmacological strategies, may be necessary to enhance patient comfort. Future research should involve larger multicenter trials to further explore these findings.

摘要

宫腔镜检查是诊断和治疗子宫内膜疾病的关键妇科手术。虽然宫腔镜检查通常在门诊进行且无需镇静,但患者在手术过程中经常报告有明显疼痛。本研究旨在评估与安慰剂相比,宫颈旁注射甲哌卡因麻醉在门诊宫腔镜检查中控制疼痛的疗效。这项随机、单中心、双盲、安慰剂对照试验于2021年6月至2022年6月在西班牙马德里的耶罗港大学医院进行。共有108名女性在宫腔镜检查前被随机分配接受2%甲哌卡因或生理盐水安慰剂。在手术的各个阶段使用视觉模拟量表(VAS)评估疼痛。结果显示,在手术过程中甲哌卡因组和安慰剂组的疼痛水平无显著差异。两组的并发症发生率和手术难度相似。影响疼痛感受的因素包括阴道分娩史和使用的器械类型,但麻醉在任何亚组中均未显示出对减轻疼痛有显著影响。我们的研究结果表明,宫颈旁注射甲哌卡因麻醉在门诊宫腔镜检查中并不能显著减轻疼痛,这与先前的研究一致。疼痛体验的差异表明,个体因素,如疼痛阈值和焦虑,可能起重要作用。可能需要一种更个性化的疼痛管理方法,结合药物和非药物策略,以提高患者的舒适度。未来的研究应包括更大规模的多中心试验,以进一步探索这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d03/11728129/d0ba8750ff23/jcm-13-07856-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d03/11728129/d0ba8750ff23/jcm-13-07856-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d03/11728129/d0ba8750ff23/jcm-13-07856-g001.jpg

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Hysteroscopy in women with abnormal uterine bleeding: a meta-analysis on four major endometrial pathologies.子宫异常出血女性的宫腔镜检查:四种主要子宫内膜病变的荟萃分析
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Pain experienced during and after office hysteroscopy with and without intracervical anesthesia.
在有或没有宫颈内麻醉的门诊宫腔镜检查期间及之后所经历的疼痛。
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