门诊子宫托取出与更换时使用麻醉乳膏：一项随机对照试验

Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial.

作者信息

Taege Susanne K, Adams William, Mueller Elizabeth R, Brubaker Linda, Fitzgerald Colleen M, Brincat Cynthia

机构信息

Departments of Obstetrics & Gynecology and Urology, Loyola University Medical Center, and the Departments of Obstetrics & Gynecology, Urology, and Physical Medicine and Rehabilitation, and the Health Sciences Division, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.

出版信息

Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.

DOI:10.1097/AOG.0000000000002098

PMID:28594757

Abstract

OBJECTIVE

To estimate the effect of lidocaine-prilocaine cream on patient pain at the time of office pessary removal and reinsertion.

METHODS

In this double-blind, randomized placebo-controlled trial, participants undergoing routine pessary care in a urogynecology office at a tertiary referral center were randomized to application of 4 g of either lidocaine-prilocaine or placebo cream 5 minutes before pessary change. Visual analog scale pain scores were collected from the patient at baseline, after pessary removal, and after pessary reinsertion. Physicians also recorded their estimate of patient pain at pessary removal and reinsertion. The primary outcome was the participant-reported visual analog scale pain score at the time of pessary removal and reinsertion. A sample size of 26 per group (n=52) was planned to estimate an absolute mean difference in visual analog scale pain of 2.1 cm at the time of pessary removal. An analysis of covariance was used to evaluate pain at removal and reinsertion as a function of treatment assignment controlling for baseline pain.

RESULTS

From July 2015 through February 2016, 116 women were screened and 54 were recruited: 28 in the lidocaine-prilocaine cream group and 26 in the placebo group. One patient in the lidocaine-prilocaine cream group was later withdrawn owing to vaginal erosion. The participants were all postmenopausal women, with an average age of 77.8 years. Most characteristics were similar between groups. After adjusting for baseline pain, participants randomized to the lidocaine-prilocaine group had lower pain at pessary removal when compared with those assigned to placebo (mean difference=-2.05, 95% confidence interval -3.69 to -0.41; P=.015).

CONCLUSION

Lidocaine-prilocaine cream use at the time of office pessary removal reduces patient-reported pain. Clinicians may wish to include this simple intervention to optimize patient comfort and compliance.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02380742.

摘要

目的

评估复方利多卡因乳膏对门诊子宫托取出和重新置入时患者疼痛的影响。

方法

在这项双盲、随机、安慰剂对照试验中，在三级转诊中心的泌尿妇科门诊接受常规子宫托护理的参与者被随机分为在更换子宫托前5分钟涂抹4克复方利多卡因乳膏或安慰剂乳膏。在基线、子宫托取出后和子宫托重新置入后收集患者的视觉模拟评分疼痛分数。医生还记录了他们对患者在子宫托取出和重新置入时疼痛程度的估计。主要结局是参与者报告的子宫托取出和重新置入时的视觉模拟评分疼痛分数。计划每组26例样本量（n = 52），以估计子宫托取出时视觉模拟评分疼痛的绝对平均差异为2.1厘米。采用协方差分析来评估作为治疗分配函数的取出和重新置入时的疼痛，并控制基线疼痛。

结果

从2015年7月至2016年2月，筛查了116名女性，招募了54名：复方利多卡因乳膏组28名，安慰剂组26名。复方利多卡因乳膏组的一名患者后来因阴道糜烂退出。参与者均为绝经后女性，平均年龄77.8岁组间大多数特征相似。在调整基线疼痛后，随机分配到复方利多卡因组的参与者与分配到安慰剂组的参与者相比，子宫托取出时的疼痛较低（平均差异 = -2.05，95%置信区间 -3.69至-0.41；P = 0.015）。