Preemptive Analgesia for Hemorrhoidectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The frequency of opioid analgesics usage
研究概览
简要总结
Preemptive analgesia with the spinal anesthesia allows to decrease pain in hemorrhoidectomy postoperative period. The purpose of this study is to assess the effectiveness of the use of preemptive analgesia with spinal anesthesia to decrease postoperative pain and the amount of used analgesics including opioids.
详细描述
Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics, patients dissatisfaction with treatment.
According to international guidelines of pain management the target level of postoperative pain should be 3-4 or less Visual Analogue Score (VAS) points. The multimodal analgesia including Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), acetaminophen and local anaesthetics are used to reach this aim.
However, there are data on effectiveness of preemptive analgesia in anorectal surgery. Preemptive analgesia allows decreasing pain in postoperative period after hemorrhoidectomy.
Ketoprophenum is used as an preemptive analgetic agent 1 hour prior to procedure.
The aim of this prospective, randomized, double-blind study is to assess the effectiveness of the use of preemptive analgesia with Ketoprophenum 10 mg 2 hours before procedure per os with spinal anaesthesia to decrease postoperative pain and the amount of used analgesics.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Patients over 18 years.
- •Symptomatic grade III-IV haemorrhoids.
- •Planned surgery: Milligan-Morgan hemorrhoidectomy
排除标准
- •Patient's refusal to participate in the study.
- •Contraindication or technical inability to perform subarachnoid anaesthesia.
- •Decompensated somatic diseases
研究组 & 干预措施
Ketoprophenum
A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
干预措施: Hemorrhoidectomy (Procedure)
Ketoprophenum
A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery
干预措施: Ketoprophenum (Drug)
Placebo
A tablet containing starch is taken per os 2 hours before surgery
干预措施: Hemorrhoidectomy (Procedure)
Placebo
A tablet containing starch is taken per os 2 hours before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
The frequency of opioid analgesics usage
时间窗: 0-7 days postoperatively
The frequency of opioid administration per day
次要结局
- Frequency of other analgesics usage(0-7 days postoperatively)
- Severity of pain(6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day)
- Duration of other analgesics usage(0-7 days postoperatively)
- Returning to work(30 days postoperatively)
- The rate of early postoperative complications(0-30 days postoperatively)
- Re-admission rate(30 days postoperatively)
- Overall quality of life(7th and 30th days postoperatively)