The Efficacy of Topical Bupivacaine and Triamcinolone Acetonide Injection in the Relief of Pain After Endoscopic Submucosal Dissection for Gastric Neoplasia: A Randomized Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Present Pain Intensity (PPI) score
研究概览
简要总结
Although pain is a common complication of endoscopic submucosal dissection (ESD), management strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and in pain associated with surgery in clinical practice. Further, triamcinolone, a type of steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for abdominal pain relief and as a potential method of pain control after ESD for gastric neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection after ESD would be effective for pain relief. For this, we designed randomized, double-blind, placebo-controlled trial. Eligible patients with early gastric neoplasm were randomized into one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone (BV-TA), or placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score and the Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12 and 24 h after ESD.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, between 20 and 80
- •Patients who were scheduled to undergo ESD for gastric epithelial neoplasm at Severance Hospital between July 2012 and April 2013
排除标准
- •Not providing written informed consent
- •A history of any cardiac arrhythmias
- •Current or regular use of analgesic medication for other indications
- •Known other disease such as peptic ulcer disease or reflux esophagitis which could induce upper gastrointestinal pain
- •Multiple lesions requiring ESD in a single patient
- •Evidence of infectious disease or antibiotics therapy within 7 days prior to enrollment
- •Participation in another clinical trial within 30 days prior enrollment
- •Current pregnancy or breast feeding.
研究组 & 干预措施
Control group
干预措施: Saline (Drug)
Bupivacaine only group
干预措施: Bupivacaine + saline (Drug)
Bupivacaine with triamcinolone group
干预措施: Bupivacaine + triamcinolone acetonide (Drug)
结局指标
主要结局
Present Pain Intensity (PPI) score
时间窗: at 6 hour after endoscopic submucosal dissection (ESD)
Present Pain Intensity (PPI) score at 6 hour after endoscopic submucosal dissection (ESD) is assessed
次要结局
未报告次要终点