Intrauterine Anesthesia in Operative, Awake, Office Hysteroscopy. A Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change in pain using a 20cm-wide VAS scale
研究概览
简要总结
Objective: to evaluate intrauterine lidocaine infusion effectiveness in reducing pain associated with operative, awake office hysteroscopy Methods: A total of 100 patients will be randomized for this study The control group underwent hysteroscopy using a saline distension medium. The study group underwent hysteroscopy using 10ml of 2% lidocaine that was added to the first liter of distension medium. Patients quantified their pain using a 0-10 VAS score, at the following five predefined points: baseline, before the procedure; while inserting the hysteroscope through the cervix; during the operative procedure; immediately after the procedure and 15 minutes following the procedure.
详细描述
- Background
Ambulatory hysteroscopy is a safe, feasible, and accurate procedure for diagnosing and treating intrauterine pathology. [1]
Office hysteroscopy does not require hospital admission, preparatory tests, and general anesthesia. Importantly, it has decreased postsurgical recovery period, global cost of the procedure, and rate of complications. [2] New approaches have evolved due to technological advances in instrumentation, an office hysteroscopy that combines diagnosis and treatment of the pathology into a single clinical procedure is referred to as "See and Treat hysteroscopy" (SATH) [3].
SATH allows diagnosis of different conditions affecting the uterine cavity in an office setting, followed immediately with treatment to resolve them, thus avoiding the patient having to undergo a subsequent procedure [4].
Pain during or after the procedure can discourage patients from undergoing office diagnostic hysteroscopy or SATH. [5] and remains a significant cause for failure to complete the procedure.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
RCT double blind
入排标准
- 年龄范围
- 20 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Women between the ages of 20 years - 52 years inclusive.
- •Undergoing SATH office hysteroscopy
- •Patients are able to provide written consent
排除标准
- •• Previous Pelvic Inflammatory Disease (PID) or documented tubal occlusion
- •Inability to consent due to cognitive or language barrier
- •Allergy to Lidocaine
- •Documented failed hysteroscopy prior to the current referral
研究组 & 干预措施
Lidocaine The study group
The study group underwent hysteroscopy using saline to which 10ml of 2% lidocaine was added to the first 1000 ml.
干预措施: Lidocaine (Drug)
Lidocaine The study group
The study group underwent hysteroscopy using saline to which 10ml of 2% lidocaine was added to the first 1000 ml.
干预措施: Saline (Drug)
Saline The control group
The control group underwent hysteroscopy using a saline distension medium.
干预措施: Saline (Drug)
结局指标
主要结局
The change in pain using a 20cm-wide VAS scale
时间窗: The change from baseline , procedure (while inserting the hysteroscope through the cervix); during the operative procedure; immediately after the procedure and 15 minutes
Patients quantified their pain using a 20cm-wide VAS scale ruler, the score range being 0-10.
次要结局
- the number of complications(up to one month following the procedure)