What is the Most Effective Local Anesthesia for Prostate-stained Ultrasonography-guided Biopsy in PPB and PNB?: A Single Center, Prospective, Randomized, Double Arm Study
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Visual analog scale-1
研究概览
简要总结
This study assesses differences in the effects of pelvic plexus block and periprostatic nerve block among various anesthetic methods that reduce the pain caused by prostate biopsy.
详细描述
Recently, various types of local anesthetic methods have been attempted to reduce biopsy-related pain leading to changes in the type of anesthetic agents and site of injection. Of these anesthetics and combinations, pelvic plexus block and periprostatic nerve block seem to be the very effective way to control prostate biopsy-related pain. However, few studies have compared these two methods.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •abnormal prostate finding on digital rectal examination
- •serum PSA level of > 2.5 ng/mL
- •Transrectal ultrasonographic abnormal lesion
排除标准
- •under 50 years old
- •a history of previous TRUS-guided biopsy
- •chronic prostatitis/pelvic pain
- •neurological conditions (dementia, Parkinson disease, or cerebral infarction)
- •bleeding diathesis
- •active UTI
- •hemorrhoids/anal fissure/anal fistula
- •known allergy to lidocaine
研究组 & 干预措施
Pelvic plexus block
The injections of 2.5 mL of 2% lidocaine were made to the pelvic neurovascular plexus located at the end of the seminal vesicle under Doppler US guidance on each side
干预措施: Pelvic plexus block (Procedure)
Periprostatic nerve block
The injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle.
干预措施: Periprostatic nerve block (Procedure)
结局指标
主要结局
Visual analog scale-1
时间窗: day 7~14
Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.
Visual analog scale-4
时间窗: day 7~14
Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.
Visual analog scale-2
时间窗: day 7~14
Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.
Visual analog scale-3
时间窗: day 7~14
Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.
次要结局
- Procedure time(day 7~14)
- Rate of Complication(day 14~28)
研究者
Kang Su Cho
associate professor
Gangnam Severance Hospital