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缓解疼痛:利多卡因喷雾剂用于孕中期羊膜腔穿刺术——一项随机双盲、安慰剂对照试验

Easing the Pain: Lignocaine Spray in Mid-Trimester Amniocentesis - A Randomized Double-Blind, Placebo-Controlled Trial.

作者信息

Sharma Tanya, Gothwal Meenakshi, Sharma Charu, Singh Pratibha, Yadav Garima, Gupta Manoj Kumar, Jhirwal Manisha, Kathuria Priyanka

机构信息

Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

Department of Community Medicine, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

出版信息

Niger Med J. 2025 Apr 3;66(1):327-336. doi: 10.71480/nmj.v66i1.737. eCollection 2025 Jan-Feb.

DOI:10.71480/nmj.v66i1.737
PMID:40309549
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12038618/
Abstract

BACKGROUND

To evaluate the effect of lignocaine spray on maternal pain perception during mid-trimester amniocentesis compared to placebo.

METHODOLOGY

This was a double-blinded, prospective, randomized controlled trial conducted at a tertiary teaching hospital in Western Rajasthan. Singleton pregnancies between 15- and 24-weeks' gestation undergoing amniocentesis were included. Participants were randomly assigned to receive either lignocaine spray or placebo (normal saline). Pain was assessed using the Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Numerical Rating Scale (NRS). A total of 138 women were enrolled, with 69 receiving lignocaine spray and 69 receiving placebos.

RESULTS

Pain perception measured by VAS showed no significant difference between the lignocaine and placebo groups (p = 0.412). VRS and VAS demonstrated a positive correlation (r = 0.692, p < 0.001). Median VAS scores at 30 minutes post-procedure were significantly lower in the lignocaine group (p = 0.008). The Kappa agreement between VAS and VRS was found to be 59.20%. No significant difference in procedure-related complications was observed between groups.

CONCLUSION

The study demonstrates no significant difference in VAS scores or secondary outcomes between the lignocaine and placebo groups, suggesting that lignocaine spray may not provide additional benefit for pain relief in amniocentesis.

摘要

背景

与安慰剂相比,评估利多卡因喷雾剂对孕中期羊膜腔穿刺术期间产妇疼痛感知的影响。

方法

这是一项在拉贾斯坦邦西部一家三级教学医院进行的双盲、前瞻性、随机对照试验。纳入妊娠15至24周进行羊膜腔穿刺术的单胎妊娠。参与者被随机分配接受利多卡因喷雾剂或安慰剂(生理盐水)。使用视觉模拟量表(VAS)、语言评定量表(VRS)和数字评定量表(NRS)评估疼痛。共招募了138名女性,其中69名接受利多卡因喷雾剂,69名接受安慰剂。

结果

通过VAS测量的疼痛感知在利多卡因组和安慰剂组之间没有显著差异(p = 0.412)。VRS和VAS呈正相关(r = 0.692,p < 0.001)。术后30分钟利多卡因组的VAS中位数得分显著更低(p = 0.008)。发现VAS和VRS之间的Kappa一致性为59.20%。两组之间未观察到与手术相关并发症的显著差异。

结论

该研究表明,利多卡因组和安慰剂组在VAS评分或次要结局方面没有显著差异,这表明利多卡因喷雾剂可能无法为羊膜腔穿刺术的疼痛缓解提供额外益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fac/12038618/c817226dd1c7/nmj-66-327-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fac/12038618/f8d647da73e3/nmj-66-327-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fac/12038618/c817226dd1c7/nmj-66-327-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fac/12038618/f8d647da73e3/nmj-66-327-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fac/12038618/c817226dd1c7/nmj-66-327-f2.jpg

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本文引用的文献

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Efficacy of lidocaine local anesthesia on pain perception during amniocentesis: A meta-analysis of randomized controlled trials.利多卡因局部麻醉对羊膜穿刺术疼痛感知的疗效:一项随机对照试验的荟萃分析。
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Effect of Xylocaine spray for analgesia during amniocentesis: a randomized controlled trial.盐酸利多卡因喷雾剂用于羊膜腔穿刺术镇痛的效果:一项随机对照试验。
Prenat Diagn. 2019 Dec;39(13):1179-1183. doi: 10.1002/pd.5559. Epub 2019 Nov 8.
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Music Listening to Decrease Pain during Second Trimester Genetic Amniocentesis: A Randomized Trial.
孕中期遗传羊膜腔穿刺术期间听音乐减轻疼痛:一项随机试验
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Reducing Pain and Anxiety during Second Trimester Genetic Amniocentesis Using Aromatic Therapy: A Randomized Trial.使用芳香疗法减轻孕中期遗传羊膜穿刺术期间的疼痛和焦虑:一项随机试验。
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Local anesthesia and pain perception during amniocentesis: a randomized double blind placebo-controlled trial.
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