Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for Pain
研究概览
简要总结
This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.
详细描述
Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the procedure. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile nerve block (DPNB) is usually used for circumcision in children and it has been shown to provide effective analgesia for penile surgeries. According to the evidence that some DNP branches innervate membranous urethra and urethra mucosa and most pain originates from cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce pain level in men during rigid cystoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status I-II
- •Without history of urethral or prostatic surgery
- •Without respiration or circulation disorders
- •Without chronic pain
排除标准
- •Allergy to local anesthetics
- •Coagulation disorder or usage of antiplatelet drugs
- •Infection at the site of puncture point
- •Severe urethral stenosis
研究组 & 干预措施
Tetracaine gel group
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
干预措施: Tetracaine (Drug)
Dorsal penile nerve block group
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
干预措施: Dorsal Penile Nerve Block (Procedure)
Dorsal penile nerve block group
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
干预措施: Ropivacaine (Drug)
Combination group
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
干预措施: Dorsal Penile Nerve Block (Procedure)
Combination group
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
干预措施: Ropivacaine (Drug)
Combination group
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
干预措施: Tetracaine (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) for Pain
时间窗: at cystoscopic inspection of external sphincter
A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
次要结局
- Visual Analog Scale (VAS) for Pain(after withdrawal of cystoscope)
- Heart Rate Before Gel Administration(before gel administration)
- Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra(at cystoscopic inspection of penile and bulbar urethra)
- Heart Rate at Cystoscopic Inspection of External Sphincter(at cystoscopic inspection of external sphincter)
- Heart Rate After Withdrawal of Cystoscope(after withdrawal of cystoscope)
- Mean Arterial Pressure Before Gel Administration(before gel administration)
- Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra(at cystoscopic inspection of penile and bulbar urthra)
- Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter(at cystoscopic inspection of external sphincter)
- Mean Arterial Pressure After Withdrawal of Cystoscope(after withdrawal of cystoscope)
- Oxygen Saturation by Pulse Before Gel Administration(before gel administration)
- Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter(at cystoscopic inspection of external sphincter)
- Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra(at cystoscopic inspection of penile and bulbar urthra)
- Oxygen Saturation by Pulse After Withdrawal of Cystoscope(after withdrawal of cystoscope)
- Breath Rate Before Gel Administration(before gel administration)
- Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra(at cystoscopic inspection of penile and bulbar Urthra)
- Breath Rate at Cystoscopic Inspection of External Sphincter(at cystoscopic inspection of external sphincter)
- Breath Rate After Withdrawal of Cystoscope(after withdrawal of cystoscope)
研究者
Yan Qiu
Attending Physician
West China Hospital