Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain on visual analog score
研究概览
简要总结
Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.
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
- None
入排标准
- 年龄范围
- 51 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:
- •Raised prostate-specific antigen level (>4.0ng/ml) and palpable nodularity on digital rectal examination
- •Palpable nodularity on digital rectal examination
- •Hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound
排除标准
- •History of previous prostate biopsy
- •Acute and/or chronic prostatitis or chronic pelvic pain syndrome
- •Anal fissure, hemorrhoids, anal surgery
- •Concomitant analgesic medication
- •Chronic renal failure
- •Allergy to diclofenac
研究组 & 干预措施
diclofenac suppository plus lidocaine gel
Intervention Drug with local anaesthetic
干预措施: Diclofenac suppository plus lidocaine gel (Drug)
diclofenac suppository plus lidocaine gel
Intervention Drug with local anaesthetic
干预措施: Lidocaine gel only (Drug)
Lidocaine gel only
Used as local aneaethetic as a part of institutional prostate biopsy protocol
干预措施: Lidocaine gel only (Drug)
结局指标
主要结局
Pain on visual analog score
时间窗: Two hours
次要结局
- Adverse effects of diclofenac suppository(two hours)
研究者
Naveed Haroon
Resident
Aga Khan University
