"Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Reduction of pain evaluated by the analgesics demand.
研究概览
简要总结
Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eutectic mixture
干预措施: Eutectic mixture (Drug)
placebo
干预措施: placebo (Drug)
Medicaina
干预措施: lidocaine 2,5%; prilocaine 2,5% (Drug)
结局指标
主要结局
Reduction of pain evaluated by the analgesics demand.
时间窗: Follow-up termination (1 month)
次要结局
- Pain reduction by VAS(Follow-up termination (1 month))
- Tolerability by the adverse events incidence(Follow-up termination (1 month))
研究者
Joaquim Simoes Neto
Master Degree
Federal University of São Paulo