LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain assessed by a 10-point visual analogue score
研究概览
简要总结
The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.
详细描述
TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All virgin women who were scheduled to undergo transrectal sonography invited to participate.
排除标准
- •Allergy to lidocaine or other local anesthetics;
- •Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
- •A bleeding diathesis and/or anticoagulant treatment;
- •Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
- •An inability to rate a visual analogue scale
研究组 & 干预措施
Placebo
Placebo (Aquagel) was administered rectally prior to probe insertion.
干预措施: Placebo (Drug)
Lidocaine gel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
干预措施: Lidocaine gel (Drug)
结局指标
主要结局
Pain assessed by a 10-point visual analogue score
时间窗: the day of the procedure (transrectal sonography)
次要结局
- Number of participants with gel-associated side effect(2 days after the procedure (transrectal sonography))
研究者
Taejong Song
Professor
Kangbuk Samsung Hospital