The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Pain assessment during the hysteroscopy
研究概览
简要总结
women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy
详细描述
Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline.
After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.
Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility
排除标准
- •Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy
研究组 & 干预措施
Lidocaine group
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy
干预措施: Lidocaine (Drug)
Lidocaine group
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy
干预措施: Office hystroscopy (Procedure)
control group
intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy
干预措施: Office hystroscopy (Procedure)
结局指标
主要结局
Pain assessment during the hysteroscopy
时间窗: during hystroscopy procedure
pain assessment during hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
次要结局
- Pain assessment 10 minutes after hysteroscopy(10 minutes after hysteroscopy)
- Pain assessment 30 minutes after hysteroscopy(30 minutes after hysteroscopy)
- Pain assessment 60 minutes after hysteroscopy(60 minutes after hysteroscopy)