Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
This study aimed to compare the efficacy of intravenous ibuprofen with peri-prostatic nerve block in pain control during prostate biopsy and to investigate factors influencing pain scores.
详细描述
This study aimed to compare the efficacy of intravenous (IV) ibuprofen with periprostatic nerve block (PPNB) in controlling pain during prostate biopsy, a common procedure used to diagnose prostate cancer. The study also aimed to investigate factors influencing pain perception during the procedure, such as prostate-specific antigen (PSA) levels, prostate volume, and comorbidities.
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
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 82 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels > 4 ng/mL.
排除标准
- •Renal failure. Liver failure. Neurological disorders (e.g., dementia, Alzheimer's disease, epilepsy, paraplegia).
- •Rectal disorders. Previous negative prostate biopsy. Chronic anticoagulant therapy or bleeding diathesis. Severe comorbidities. Psychiatric conditions interfering with consent or compliance.
研究组 & 干预措施
Periprostatic nerve block
Periprostatic Nerve Block (PPNB) using 2% lidocaine was administered for pain relief during the prostate biopsy procedure.
干预措施: periprostatic nerve block (Other)
Ibuprofen group
Each patient in Group 1 received 400 mg of IV ibuprofen diluted in 100 mL of solution. The infusion was administered over a 30-minute period to ensure proper absorption and minimize adverse effects.
干预措施: intravenous ibuprofen (Other)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure
Pain Assessment using Visual Analog Scale (VAS),The Visual Analog Scale (VAS) is a tool used to measure subjective characteristics or attitudes that cannot be directly measured. It typically consists of a 10 cm (100 mm) horizontal or vertical line, anchored by two endpoints representing extremes of the sensation being measured. Range: Scores range from 0 (minimum) to 10 (maximum). Interpretation: Higher scores indicate a worse outcome (e.g., greater pain intensity or distress). Description: Participants mark a point along the line that corresponds to the intensity of their experience. The score is determined by measuring the distance (in centimeters or millimeters) from the lower end of the scale to the participant's mark.
次要结局
- Complications(immediately after the intervention/procedure/surgery)
研究者
Elzem SEN
Assoc. Prof.Dr
University of Gaziantep