Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- age
研究概览
简要总结
Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomized controlled comparative prospective clinical trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sex.
- •age from 18 to 60.
排除标准
- •patient refusal.
- •patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy.
- •patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.
研究组 & 干预措施
group A: ketorolac and light marcaine injection
干预措施: ketorolac and light marcaine (Drug)
group B: light marcaine injection
干预措施: light marcaine (Drug)
group C: corticosteroids injection
干预措施: Corticosteroids injection (Drug)
group D: topical diclofenac sodium
干预措施: Diclofenac Sodium Gel (Drug)
control group
control group was given the ordinary analgesic protocol without local analgesic application
干预措施: the standard analgesic protocol (Other)
结局指标
主要结局
age
时间窗: within 2 days before operation
adults from 18 to 60 years old
sex
时间窗: within 2 days before operation
both sex were included
number of hemorrhoids
时间窗: within 2 days before operation and intra-operatively
number of hemorrhoids clinically assessed
degree of hemorroids
时间窗: within 2 days before operation and intra-operatively
degree of hemorroids clinically assessed
post operative pain
时间窗: 1st, 2nd 3rd, 7th, 14th days post-operatively
post operative assessed using visual analogue scale, minimum score is zero means painless and maximum score 10 means very painful
ambulation
时间窗: from 1st to 3rd day post-operatively
early ambulation is evaluated in patients post-operatively
return to work
时间窗: from one day to one month post-operatively
first time to return to work is evaluated
patient satisfaction
时间窗: from one day to one month post-operatively
patient satisfaction about post-operative pain is assessed using customer satisfaction score. Minimum score is 0 and means very unsatisfied, maximum score is 10 and means very satisfied
次要结局
未报告次要终点
研究者
Reham Zakaria Mohamed Ahmed
Principal Investigator
Zagazig University