Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac suppository during flexible cystoscopy has been proven to be effective. This study was done to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients
详细描述
Consecutive consenting male patients undergoing DJ stent removal under local anesthesia during 2014-15 were enrolled. Patients were randomized to receive 75 mg oral diclofenac or placebo 1 hour prior to procedure by double blind randomization. Intraurethral 2% lignocaine jelly (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at first void and at 24 hours after cystoscopy was assessed using visual analogue scale [VAS] (0 to 100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All consecutive consenting male patients aged more than 18 years, undergoing DJ stent removal under local anesthesia (2% Lignocaine jelly) during the study period will be included.
排除标准
- •Patients unable to understand visual analogue pain score
- •Age < 18 years
- •Presence of Lower Urinary Tract Symptoms prior to surgery
- •Presence of prostatitis or urethral stricture during cystoscopy
- •Patients with renal failure (Serum creatinine > 1.3 mg/dl)
- •Patients on concomitant nephrotoxic drugs
- •Patients with history of peptic ulcer or upper gastrointestinal bleed or upper abdominal surgeries
- •Loss to follow up at 24 hours following DJ stent removal
研究组 & 干预措施
Diclofenac sodium
Oral diclofenac 75 mg one hour prior to stent removal
干预措施: Diclofenac sodium (Drug)
Placebo
Placebo one hour prior to stent removal
干预措施: Placebo (Drug)
结局指标
主要结局
Pain
时间窗: Intraoperative upto 24 hours postoperative
Pain during stent removal, first void and 24 hours after procedure
次要结局
- Adverse reactions(24 hours)
研究者
Vilvapathy Senguttuvan Karthikeyan
MCh Urology Postgraduate in Urology
Institute of Nephro Urology, Bangalore