Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 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 orthopedic operations.
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)
- Adverse effects of the drug(All adverse effects observed in the first 24 hours postoperatively)
- Assessment of postoperative sedation(In the operating theatre immediately after patient's extubation)
研究者
Georgia Micha
Principal Investigator, Anesthesiologist,MD, MSc, PhD
Saint Savvas Anticancer Hospital