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子宫输卵管泡沫超声检查中子宫内利多卡因冲洗的镇痛效果:一项双盲随机对照试验

Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial.

作者信息

Melcer Yaakov, Nimrodi Maya, Levinsohn-Tavor Orna, Gal-Kochav Maayan, Pekar-Zlotin Marina, Maymon Ron

机构信息

From the Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (all authors)..

From the Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (all authors).

出版信息

J Minim Invasive Gynecol. 2021 Aug;28(8):1484-1489. doi: 10.1016/j.jmig.2020.11.019. Epub 2020 Nov 26.

DOI:10.1016/j.jmig.2020.11.019
PMID:33249268
Abstract

STUDY OBJECTIVE

To evaluate the efficacy of flushing the uterine cavity with lidocaine before hysterosalpingo-foam sonography (HyFoSy) to reduce procedure-related pain.

DESIGN

A double-blind randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Shamir Medical Center, Israel between June 2020 and September 2020 involving 80 women undergoing a HyFoSy procedure.

SETTING

University-affiliated medical center.

PATIENTS

A total of 40 women were assigned randomly to the lidocaine group and 40 to the saline (placebo) group using a predetermined randomization code. Intrauterine instillation before the procedure consisting of either lidocaine 2% or normal saline alone was conducted, respectively.

INTERVENTIONS

The primary outcome measure was the visual analog scale (VAS) pain score during the phase of intrauterine foam instillation reported by the women after the procedure. The VAS consisted of a 10-cm line ranging from 0 to 10 (anchored by 0 = no pain and 10 = very severe pain). On the basis of the VAS scores, the pain level ratings were classified as mild (rated 1-3), moderate (4-6), or severe (7-10).

MEASUREMENTS AND MAIN RESULTS

The patient characteristics and obstetric data were found to be similar in both groups. Comparison of the VAS pain scores experienced during the procedure showed that women in the lidocaine flushing group rated the procedure less painful than the women in the saline group (3.0 ± 1.3 vs 6.3 ± 1.5, respectively; p = .001). The incidence of severe pain was significantly lower in the lidocaine group than the saline group (2.5% and 45.0%, respectively, p = .001).

CONCLUSION

Lidocaine flushing of the uterine cavity before HyFoSy significantly decreased the pain known to be caused by this procedure and had the advantage of no side effects. It is easily applied, relatively inexpensive, and may affect compliance with this procedure.

摘要

研究目的

评估在子宫输卵管泡沫超声造影(HyFoSy)前用利多卡因冲洗子宫腔以减轻与手术相关疼痛的疗效。

设计

2020年6月至2020年9月,在以色列沙米尔医疗中心妇产科进行了一项双盲随机对照试验,纳入80例行HyFoSy手术的女性。

地点

大学附属医疗中心。

患者

使用预定随机编码,将40名女性随机分配至利多卡因组,40名女性随机分配至生理盐水(安慰剂)组。术前分别进行子宫内灌注,灌注液分别为2%利多卡因或单纯生理盐水。

干预措施

主要结局指标为术后女性报告的子宫内泡沫灌注阶段的视觉模拟量表(VAS)疼痛评分。VAS由一条10厘米长的线组成,范围从0到10(两端分别为0 = 无疼痛和10 = 非常严重疼痛)。根据VAS评分,疼痛程度分为轻度(评分为1 - 3)、中度(4 - 6)或重度(7 - 10)。

测量指标及主要结果

两组患者的特征和产科数据相似。手术过程中VAS疼痛评分比较显示,利多卡因冲洗组女性对手术的疼痛评分低于生理盐水组(分别为3.0±1.3和6.3±1.5;p = 0.001)。利多卡因组的重度疼痛发生率显著低于生理盐水组(分别为2.5%和45.0%,p = 0.001)。

结论

HyFoSy前用利多卡因冲洗子宫腔可显著减轻该手术已知引起的疼痛,且具有无副作用的优点。其应用简便、成本相对较低,并可能影响该手术患者的依从性。

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