Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain assessment assessed using visual analogue score from 0-10
研究概览
简要总结
Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.
详细描述
A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included
排除标准
- •Patients with grade I/II internal hemorrhoids or external hemorrhoids.
- •Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\
- •Patients with recurrent hemorrhoids after previous surgery.
研究组 & 干预措施
Hemorrhoidectomy
Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
干预措施: Hemorrhoidectomy (Procedure)
trimebutine
Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.
干预措施: Trimebutine (Drug)
trimebutine
Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.
干预措施: Hemorrhoidectomy (Procedure)
结局指标
主要结局
Pain assessment assessed using visual analogue score from 0-10
时间窗: Pain will be assessed at 12 hours after the procedure
Anal pain will be assessed using visual analogue score from 0-10
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University