CTRI/2021/11/038199尚未招募4 期
Comparative study of oral pregabalin versus oral amitriptyline as preemptive analgesic agent in patients undergoing inguinal hernioplasty surgeries under spinal anaesthesia.
Dr Anitha1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年11月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of pregabalin and amitriptyline in the prevention of postoperative pain
研究概览
简要总结
This study is a prospective, randomised, double blinded, placebo controlled study to evaluate the postoperative analgesic benefit in patients administered with pregabalin or amitriptyline as premedication for patients undergoing inguinal hernioplasty surgeries under spinal anaesthesia and to compare their postoperative efficacy with respect to increase in duration of analgesia, reduction in total postoperative requirement of analgesics and study the adverse effects, if attributable to both drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anaesthesiologists physical status 1 and 2 2.Patients posted for elective inguinal hernioplasty surgery.
排除标准
- •1.Patient refusal 2.Known sensitivity to Pregabalin and Amitriptyline 3.History of seizure disorder 4.Known psychiatric disorder 5.History of chronic pain and chronic daily intake of analgesic 6.Liver or renal disease 7.History of drug or alcohol abuse 8.Pregnancy and breastfeeding mothers.
结局指标
主要结局
To evaluate the effectiveness of pregabalin and amitriptyline in the prevention of postoperative pain
时间窗: 24 hours post surgery
次要结局
- Use of rescue analgesics(24 hours post surgery)
- Side effects of pregabalin and amitriptyline(24 hours post surgery)
- To measure intensity of acute postoperative pain(24 hours post surgery)
研究者
研究点 (1)
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