Bladder Irrigation With 0.05% Lidocaine Normal Saline Solution for Prevent Postoperative Catheter Related Bladder Discomfort (CRBD) Under ANI Monition After Transurethal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- using Numerical rating scale to measure pain alleviate
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing, and it may get worse in patients undergoing transurethral surgery for damage urethra by a surgical instrument as well as a sizable and urinary catheter placement. Lidocaine, a local anesthetic, showed of analgesic, sedative, and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort.
详细描述
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing. It is not unusual that patients who have been catheterized under anesthesia complain of an urge to void in the postoperative period because of catheter-related bladder irritation. Bladder catheterization induces bladder irritation whose symptoms (urge to void and discomfort in the suprapubic region) are similar to the symptoms of an overactive bladder (urinary frequency and urgency with or without urge incontinence), caused by involuntary contractions of the bladder mediated by muscarinic receptors. The discomforts are quickly getting worse in patients undergoing transurethral surgery by a surgical instrument as well as a sizable urinary catheter placement. Recently, antimuscarinic drugs for treat overactive bladder, such as tolterodine and oxybutynin, have been tried for prevention of CRBD with variable success. However, they may cause side effect including palpitation, dry mouth, drowsiness, dizziness or headache. Lidocaine, a local anesthetic, showed of analgesic, sedative and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort.
Objectives:
The aim of this study were:
- to evaluate the efficacy to prevent CRBD with Bladder irrigation with 0.05% Lidocaine normal saline solution
- to observe the change of vital sign with Bladder irrigation with 0.05% Lidocaine normal saline solution
- to see the side effect of with Bladder irrigation with 0.05% Lidocaine normal saline solution
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients who received regular transurethral surgery were inserted left foley catheter for urine drainage or bladder irrigation.
- •American Society of Anesthesiologists(ASA)class:Ι-Ⅲ
- •Age:20-70years
排除标准
- •Lidocaine allergy
- •cardiac conduction with partial or total block
- •patient with progressive hepatic or renal impairment
- •patient with class III anti-arrhythmia agent(ex:amiodarone)
- •patient with acute porphyria
研究组 & 干预措施
Study group
Study group: using 0.05% Lidocaine normal saline solution for bladder irrigation
干预措施: 0.05% Lidocaine (Drug)
结局指标
主要结局
using Numerical rating scale to measure pain alleviate
时间窗: 6 hours
measurement of numerical pain rating scale from 0 (no pain): no pain to 10 (severe pain intolerable) as maintain the score of analgesia nociception index within 50-70 ( over 70 may need to evaluate analgesia overdose and under 50 to evaluate pain or hemodynamic changes)
using catheter-related bladder discomfort score to evaluate CRBD alleviation
时间窗: 6 hours
measurement of catheter-related bladder discomfort score (grade 1: none, grade II: mild, grade III: moderate, grade IV: severe
次要结局
- using the sphygmomanometer to monitor blood pressure(6 hours)
- checking the heart rate of patient by the pulse oximeter(6 hours)
- monitoring the hemodynamic changes by using the analgesia nociception index(ANI)(6 hours)
- checking the physiological response, vomiting or not(6 hours)
- measure the physiological response to the hypothermia of patient(6 hours)
- measuring the amount of oxygen in the blood(6 hours)
- assess the electrolyte imbalance by checking the content of Na(6 hours)
- assess the electrolyte imbalance by checking the content of K(6 hours)
- assess the electrolyte imbalance by checking the content of Ca++(6 hours)
研究者
Chia-Heng Lin, MD
Physician
Kaohsiung Medical University Chung-Ho Memorial Hospital