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临床试验/ACTRN12616001477415
ACTRN12616001477415招募中不适用

Compound topical Gabapentin, Amitriptyline, and Lignocaine ointment vs placebo for post­haemorrhoidectomy analgesia – a prospective double­blinded randomised controlled trial

Monash Health0 个研究点目标入组 166 人开始时间: 2016年10月24日最近更新:
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试验速览

阶段
不适用
状态
招募中
发起方
Monash Health
入组人数
166
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 80 Years（—）
性别
All

入选标准

  • •Adult patients of any sex between age 18-80 years old, with American Society of Anesthesiologists (ASA) physical status I to III, who is scheduled for elective formal haemorrhoidectomy for grade III or IV haemorrhoids under general anaesthesia.

排除标准

  • •Patients with impaired decision-making ability, incapable to consent for procedure, perceived inability to complete pain diary, allergy to the Gabapentin, Amitriptyline, or Lignocaine, history of drug and alcohol abuse, opioid dependence, or do not have the capacity to weigh up potential risks and benefits of the trial will be excluded. Pregnant women, children or patients with disease states or terminal organ impairment will also be excluded from the study. Written and verbal informed consent will be obtained from all patients.
  • •If during post-operative follow-up, patients were found to have surgical site infection, they will be excluded from the final analysis of pain control. These patients will still be included in the secondary comparative analysis between the two randomised groups.

研究者

发起方
Monash Health

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