跳至主要内容
临床试验/NCT01939743
NCT01939743已完成2 期

Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Intervention Drug with local anaesthetic

干预措施: Diclofenac suppository plus lidocaine gel (Drug)

diclofenac suppository plus lidocaine gel

Experimental

Intervention Drug with local anaesthetic

干预措施: Lidocaine gel only (Drug)

Lidocaine gel only

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naveed Haroon

Resident

Aga Khan University

研究点 (1)

Loading locations...

相似试验