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临床试验/NCT02863679
NCT02863679已完成不适用

Topical Anesthesia of Tetracaine Hydrochloride Jelly on Cervix After Hysteroscopic Uterine Stent Insertion

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年5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
入组人数
84
试验地点
1
主要终点
Numerical Rating Scale (NRS) score

研究概览

简要总结

This study was taken out to assess the postoperative analgesic efficacy of tetracaine hydrochloride gel in patients with intrauterine adhesion treating with intrauterine balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel group and control group.

详细描述

Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics. Patients in getracaine hydrochloride gel group were covered with a gauze of tetracaine hydrochloride gel on the external cervical orifice after insert an utrauterine balloon in the uterine cavity. While patients in the control group were covered with a blank gauze after hysteroscopic adhesiolysis. Compare the postoperative analgesic scor and patients' analgesic satisfaction of the two groups and asess the analgesic efficacy of tetracaine hydrochloride gel.

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
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • no previous history of hysteroscopic adhesiolysis or surgery on the cervix
  • inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis
  • no other diseases

排除标准

  • Allergy to local anesthetics
  • Patients with chronic pain
  • Patients with abnormal blood coagulation function
  • Patients with mental illness that can not cooperate
  • Patients with previous hysteroscopic adhesiolysis or cervical surgery

研究组 & 干预措施

Tetracaine hydrochloride gel group

Experimental

Patients in getracaine hydrochloride gel group were covered with a gauze with tetracaine hydrochloride gel on the cervix after hysteroscopic insertion of utrauterine balloon stent.

干预措施: Tetracaine hydrochloride gel (Drug)

Control group

Placebo Comparator

Patients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent.

干预措施: Tetracaine hydrochloride gel (Drug)

结局指标

主要结局

Numerical Rating Scale (NRS) score

时间窗: 7 days

次要结局

  • patients received balloon volume reduction(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng Lin

attending doctor

Wenzhou Medical University

研究点 (1)

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