跳至主要内容
临床试验/NCT02039661
NCT02039661已完成不适用

Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Kayseri Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Pain Score

研究概览

简要总结

The effect of lidocaine spray on pain relief during endometrial sampling.

详细描述

The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

We will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age>18 years no allergy Patients with abnormal uterine bleeding

排除标准

  • cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

研究组 & 干预措施

Lidocaine Spray

Active Comparator

干预措施: Lidocaine Spray (Drug)

Placebo

Placebo Comparator

These patients received placebo spray.

干预措施: Placebo (Drug)

结局指标

主要结局

Pain Score

时间窗: 3 months

Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was performed at 3 different time points: immediately before to the procedure, during the procedure (immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients were asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

次要结局

未报告次要终点

研究者

发起方
Kayseri Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gökhan Açmaz

MD

Kayseri Education and Research Hospital

研究点 (1)

Loading locations...

相似试验