Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
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 during coughing
研究概览
简要总结
Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients planned for elective laparoscopic hernia repair (TAPP)
- •Unilateral inguinal or femoral hernia
- •ASA class I-II
- •Read and speak Danish
排除标准
- •Acute hernia operation
- •Operation for other hernias with mesh during the same procedure
- •Endocrine disease (diabetes, adrenal insufficiency etc.)
- •fever/infection within the first 10 days before operation
- •Poor compliance
- •No signed consent form
- •Daily intake of opioids or anxiolytic drugs
- •Manic episodes
- •Use medicine against glaucoma
- •Use thiazide or loop diuretics
- •Vaccination within the last 14 days
研究组 & 干预措施
Placebo
Saline
干预措施: Saline (Drug)
Dexamethasone
Corticosteroid (Fortecontin 8 mg)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
pain during coughing
时间窗: day 1
Assessed with visual analog scale (VAS 0-100 mm)
次要结局
- convalescence(1 month)
- pain during coughing(4 days)
- pain at rest(4 days)
- nausea(2 days)
- vomiting(2 days)
- discomfort(4 days)
- fatigue(4 days)
研究者
Mette Astrup Madsen
M.D.
Zealand University Hospital