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腹腔镜输卵管结扎术中腹腔内应用利多卡因缓解疼痛:一项双盲随机对照试验。

Pain relief in laparoscopic tubal ligation using intraperitoneal lignocaine: a double masked randomized controlled trial.

机构信息

Department of Obstetrics & Gynecology, Kasturba Medical College and Dr TMA Pai Rotary Hospital, Karkala, Manipal University, Manipal, Karnataka, India.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):110-4. doi: 10.1016/j.ejogrb.2012.06.035. Epub 2012 Jul 21.

DOI:10.1016/j.ejogrb.2012.06.035
PMID:22819575
Abstract

OBJECTIVE

The intraperitoneal route of analgesia has been studied over the years for effective perioperative pain relief during minimally invasive surgery, but there were conflicting reports of the use of intraperitoneal analgesic administration and moreover there was no consensus regarding the dose and type of drugs used. We report a randomized trial to assess the safety and effectiveness of intraperitoneal lignocaine as an intraoperative and postoperative analgesic in laparoscopic tubal ligation.

STUDY DESIGN

This is a double masked, randomized parallel group placebo-controlled trial of women seeking laparoscopic sterilization under local anaesthesia at a university hospital. The intervention group and placebo group received 20 ml of 0.5% lignocaine and 20 ml of isotonic saline intraperitoneally respectively. Allocation concealment was done by fixed block randomization. The participating women, the surgeon, anaesthetist, technician and the doctor who assessed the pain score were masked to the type of intervention. Intraoperative and postoperative pain was assessed by visual analogue pain scale and the scores are expressed as mean difference (95% confidence interval) between groups. Our trial is registered with the Clinical Trials Registry, India (http://www.ctri.nic.in/, CTRI/2009/091/000072).

RESULTS

Out of 200 women recruited, 196 were available for final analysis with 98 women in each arm. The mean difference in the intraoperative pain score at the time of tubal ligation was 3.5 cm (95% CI 2.91-4.09). The mean difference in the postoperative pain scores at half an hour was 2.9 (95% CI 2.50-3.44), 1h was 2.5 (95% CI 2.08-3.00) and 3h was 1.2 (95% CI 0.75-1.76). There was no case of adverse reaction to lignocaine.

CONCLUSION

Our findings show that intraperitoneal instillation of lignocaine is a safe and effective method for perioperative pain relief during laparoscopic tubal occlusion performed under conscious sedation.

摘要

目的

多年来,人们一直在研究腹腔内镇痛途径,以在微创外科手术期间有效缓解围手术期疼痛,但腹腔内镇痛给药的使用存在相互矛盾的报道,而且对于使用的药物剂量和类型也没有共识。我们报告了一项随机试验,以评估腹腔内利多卡因作为腹腔镜输卵管结扎术中术中和术后镇痛剂的安全性和有效性。

研究设计

这是一项在一所大学医院进行的局部麻醉下寻求腹腔镜绝育的妇女的双盲、随机平行组安慰剂对照试验。干预组和安慰剂组分别接受 20 毫升 0.5%利多卡因和 20 毫升等渗盐水腹腔内给药。通过固定块随机化进行分配隐藏。参与的女性、外科医生、麻醉师、技术人员和评估疼痛评分的医生对干预类型进行了盲法。通过视觉模拟疼痛量表评估术中和术后疼痛,评分表示为组间差异(95%置信区间)。我们的试验已在印度临床试验注册处注册(http://www.ctri.nic.in/,CTRI/2009/091/000072)。

结果

在招募的 200 名女性中,有 196 名女性最终可用于分析,每组 98 名女性。输卵管结扎时术中疼痛评分的平均差异为 3.5 厘米(95%置信区间 2.91-4.09)。半小时后疼痛评分的平均差异为 2.9(95%置信区间 2.50-3.44),1 小时为 2.5(95%置信区间 2.08-3.00),3 小时为 1.2(95%置信区间 0.75-1.76)。没有利多卡因不良反应的病例。

结论

我们的研究结果表明,在清醒镇静下进行腹腔镜输卵管闭塞术期间,腹腔内注入利多卡因是一种安全有效的围手术期镇痛方法。

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