Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
研究概览
简要总结
The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to urological operations because of the high incidence of CRBD observed in this kind of surgical population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients about to be subjected to urinary operations
- •Signed informed consent
排除标准
- •Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
- •History of overactive ((urinary frequency>3 times at night and >8 times in 24 hours), neurogenic bladder
- •End stage renal failure
- •Central nervous system dysfunction
- •Mental illness/ substance abuse
- •Sensitivity to pregabalin
- •Preoperative administration of pregabalin for other indications
- •Recent bladder catheterization <3 months
研究组 & 干预措施
Group I
Administration of a placebo capsule 1 hour prior to the surgical operation
干预措施: Placebo oral capsule (Drug)
Group II
Administration of 75mg of pregabalin 1 hour prior to the surgical operation
干预措施: Pregabalin Oral Capsule [Lyrica] 75mg (Drug)
Group III
Administration of 150mg of pregabalin 1 hour prior to the surgical operation
干预措施: Pregabalin Oral Capsule [Lyrica] 150 mg (Drug)
结局指标
主要结局
Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
时间窗: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)
次要结局
- Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)(Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively)
- Assessment of postoperative sedation(In the operating theatre immediately after patient's extubation)
- Adverse effects of the drug(All adverse effects observed in the first 24 hours postoperatively)
研究者
Georgia Micha
Anesthesiologist,MD, MSc, PhD
Saint Savvas Anticancer Hospital