Intrauterine Lidocaine Instillation and Pain Scores Among Women Undergoing Hysteroscopy-Guided Biopsy: A Randomized Controlled Trial.

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrics and gynecology Pub Date : 2025-06-12 DOI:10.1097/AOG.0000000000005972

Aishwarya Thalappan Puliyullaveettil, Murali Subbaiah, Chitra Thyagaraju, Divya Bhukya

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引用次数: 0

Abstract

Objective: To compare the visual analog scale (VAS) score for pain and assess patient satisfaction and complications in women receiving intrauterine anesthesia with those receiving placebo during hysteroscopic-guided biopsy.

Methods: The study was conducted in a tertiary care hospital over 17 months, from August 2021 to December 2022. One hundred twenty-six women scheduled for outpatient hysteroscopy-guided biopsy were included in this study and randomized either to the lidocaine (2% 5-mL solution) group or placebo group (63 individuals each). The study adopted a novel approach of vaginoscopic hysteroscopy that employed an intrauterine insemination catheter insertion and administered 2% (5 mL) lidocaine to the lidocaine group or saline (5 mL) to the placebo group. Pain scoring was carried out using the VAS scoring scale at hysteroscope insertion, during hysteroscopic-guided biopsy and after 10 minutes, 30 minutes, and 60 minutes of biopsy. Patient satisfaction level was assessed using the Likert scale. The primary objective was to compare the VAS score for pain between the groups during hysteroscopic-guided biopsy. Power analysis was performed in OpenEpi v3.01 software, using the log-transformed mean difference and standard deviation of the primary outcome (VAS score) of the study groups.

Results: The median [interquartile range] VAS pain scores during hysteroscopic-guided biopsy were significantly higher in the placebo group (5 [5-6]) compared with the anesthesia group (4 [3-5]) (P<.001). Similar results were noted during insertion of hysteroscope and at 10, 30, and 60 minutes after biopsy. Patients' satisfaction levels were significantly higher in the anesthesia group (30.2% were very satisfied) compared with the placebo group (1.6% were very satisfied) (P<.001).

Conclusion: Intrauterine lidocaine instillation during vaginoscopic hysteroscopy-guided biopsy significantly reduced the pain during and after the procedure. It also improved the satisfaction of the patients after office hysteroscopy. No complications or side effects were associated with intrauterine lidocaine.

Clinical trial registration: Clinical Trials Registry India (CTRI), CTRI/2021/07/034679.

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宫腔镜引导下活检妇女宫腔内利多卡因灌注和疼痛评分：一项随机对照试验。

目的：比较宫腔镜引导下宫内麻醉组与安慰剂组的疼痛视觉模拟评分（VAS），并评估患者满意度和并发症。方法：研究于2021年8月至2022年12月在一家三级医院进行，为期17个月。126名计划在门诊宫腔镜指导下进行活检的妇女被纳入本研究，并随机分为利多卡因（2% 5-mL溶液）组和安慰剂组（各63人）。本研究采用阴道镜宫腔镜新方法，置入宫内人工授精导管，利多卡因组给予2% （5ml）利多卡因，安慰剂组给予生理盐水（5ml）。在宫腔镜插入时、宫腔镜引导下活检时、活检10分钟、30分钟和60分钟后，采用VAS评分量表进行疼痛评分。采用李克特量表评估患者满意度。主要目的是比较两组在宫腔镜引导下活检时疼痛的VAS评分。在OpenEpi v3.01软件中进行功率分析，采用各组主要结局（VAS评分）的对数变换平均差和标准差。结果：与麻醉组（4[3-5]）相比，安慰剂组（5[5-6]）在宫腔镜引导下活检时VAS疼痛评分中位数（4[5-6]）明显更高(p结论：阴道镜下宫腔镜引导下活检时宫腔内注入利多卡因可显著减轻术中及术后疼痛。提高了宫腔镜术后患者的满意度。子宫内使用利多卡因无并发症或副作用。临床试验注册：印度临床试验登记处（CTRI）， CTRI/2021/07/034679。

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来源期刊

Obstetrics and gynecology 医学-妇产科学

CiteScore

11.10

自引率

4.20%

发文量

867

审稿时长

1 months

期刊介绍： "Obstetrics & Gynecology," affectionately known as "The Green Journal," is the official publication of the American College of Obstetricians and Gynecologists (ACOG). Since its inception in 1953, the journal has been dedicated to advancing the clinical practice of obstetrics and gynecology, as well as related fields. The journal's mission is to promote excellence in these areas by publishing a diverse range of articles that cover translational and clinical topics. "Obstetrics & Gynecology" provides a platform for the dissemination of evidence-based research, clinical guidelines, and expert opinions that are essential for the continuous improvement of women's health care. The journal's content is designed to inform and educate obstetricians, gynecologists, and other healthcare professionals, ensuring that they stay abreast of the latest developments and best practices in their field.