临床试验/NCT06769204

NCT06769204尚未招募3 期

Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

Cairo University0 个研究点目标入组 90 人开始时间: 2025年2月10日最近更新: 2025年1月10日

适应症

干预措施

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Cairo University
入组人数: 90
主要终点: pain during Cervical instrumentation of the tenaculum and cannula

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility

详细描述

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.

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 45 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

排除标准

•Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.
•Current pregnancy or suspicion of pregnancy.
•Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
•Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.

研究组 & 干预措施

lidocaine prilocaine

Experimental

干预措施: EMLA SPRAY (Drug)

placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

pain during Cervical instrumentation of the tenaculum and cannula

时间窗: 1 minute

pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt

次要结局

pain At the end of uterine filling(5 minutes)

研究者

发起方

Cairo University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ahmed Samy aly ashour

professor

Cairo University

相似试验

尚未招募

4 期

Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized StudyOffice Hysteroscopy

NCT06767085Cairo University106

进行中（未招募）

不适用

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum AspirationPain, ProceduralLidocaineObstetric Surgical Procedures

NCT06344637UdonThani Hospital216

已完成

不适用

Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled TrialPain Score

NCT02007408Kayseri Education and Research Hospital108

Unknown

4 期

Cervical Lidocaine-Prilocaine Cream vs Glyceryl Trinitrate Cream in Nulliparous Women With LNG-IUD InsertionContraception

NCT04355598Cairo University195

Unknown

4 期

Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD InsertionContraception

NCT04339361Cairo University111