Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence and severity of CRBD
研究概览
简要总结
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.
详细描述
CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia.
In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed
- •Male adult patient, aged 18~50 years old, ASA I~III
- •Surgery under general anesthesia
排除标准
- •Bladder dysfunction, such as overactive bladder
- •A history of bladder outflow obstruction
- •Prostate disease, such as benign prostate hyperplasia, etc.
- •Disturbance of central nervous system
研究组 & 干预措施
DPNB
Patients receive DPNB 30min before extubation at the end of operation.
干预措施: DPNB (Procedure)
Tramadol
Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
干预措施: Tramadol (Drug)
结局指标
主要结局
Incidence and severity of CRBD
时间窗: up to 6 months
次要结局
- Visual analogue scale (VAS) for postoperative pain(up to 6 months)
- Postoperative fentanyl requirement(up to 6 months)
- Side effects(up to 6 months)
研究者
Ren Liao
Doctor, Associate professor
West China Hospital