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利多卡因软膏与安慰剂治疗产后会阴部疼痛的随机试验

Randomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain.

作者信息

Minassian Vatche A, Jazayeri Allahyar, Prien Sam D, Timmons Rebecca L, Stumbo Keeli

机构信息

Division of Urogynecology, Department of Obstetrics and Gynecology, University of Toronto, Ontario, Canada.

出版信息

Obstet Gynecol. 2002 Dec;100(6):1239-43. doi: 10.1016/s0029-7844(02)02339-6.

Abstract

OBJECTIVE

To estimate the efficacy of lidocaine ointment in relieving pain after a vaginal delivery with an episiotomy or perineal laceration.

METHODS

In a randomized, double-blind, placebo-controlled trial, 200 women received lidocaine ointment (n = 108) or a placebo (n = 92). Pain relief was assessed by the amount of ointment used (weight of jar before use - weight of jar after use), total number of pain pills used, and a pain questionnaire. The sample size was calculated using a beta of.2 and an alpha of.05 with an expected reduction of other pain medications from an average use of six pills to four pills for the population.

RESULTS

There was no significant difference in the amount of lidocaine versus placebo used for postpartum day 1 (5.1 g versus 4.0 g, respectively [P =.13]) or day 2 (3.7 g versus 2.6 g, respectively [P =.18]). Patients receiving lidocaine instead of the placebo showed no significant difference in the total amount of postpartum pain medications (6.3 versus 6.8 tablets, respectively [P =.53]), subjective pain parameters (P =.36), or satisfaction from ointment (P =.99). Patients with an episiotomy used more pain medications than those with a laceration (7.9 versus 5.6 tablets, respectively [P =.003]). Those with minor versus major lacerations required fewer pain pills (6.1 versus 10.8 tablets, respectively [P <.001]) and used less ointment (4.3 g versus 7.9 g, respectively [P =.02]) on the first postpartum day.

CONCLUSION

Topical application of 5% lidocaine ointment was not effective in relieving episiotomy or perineal laceration pain.

摘要

目的

评估利多卡因软膏在缓解阴道分娩会阴切开术或会阴裂伤后疼痛方面的疗效。

方法

在一项随机、双盲、安慰剂对照试验中,200名女性接受了利多卡因软膏(n = 108)或安慰剂(n = 92)。通过使用的软膏量(使用前药罐重量 - 使用后药罐重量)、使用的止痛片总数和疼痛问卷来评估疼痛缓解情况。样本量是根据β为0.2和α为0.05计算得出的,预计总体中其他止痛药物的使用量将从平均6片减少到4片。

结果

产后第1天使用的利多卡因与安慰剂量无显著差异(分别为5.1克和4.0克[P = 0.13])或第2天(分别为3.7克和2.6克[P = 0.18])。接受利多卡因而非安慰剂的患者在产后止痛药物总量(分别为6.3片和6.8片[P = 0.53])、主观疼痛参数(P = 0.36)或对软膏的满意度(P = 0.99)方面无显著差异。会阴切开术患者使用的止痛药物比裂伤患者多(分别为7.9片和5.6片[P = 0.003])。产后第一天,轻度裂伤患者与重度裂伤患者相比,所需止痛片更少(分别为6.1片和10.8片[P < 0.001]),使用的软膏更少(分别为4.3克和7.9克[P = 0.02])。

结论

局部应用5%利多卡因软膏在缓解会阴切开术或会阴裂伤疼痛方面无效。

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