The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- visual analogue scale (VAS )
研究概览
简要总结
The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
详细描述
The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age
- •body mass index <35,
- •renal stone size >2.0 cm.
排除标准
- •patients having supra-costal puncture.
- •excessive intraoperative bleeding.
- •renal stones requiring more than a single puncture.
- •surgical procedure extending more than 3 hours.
- •urinary tract infection.
- •severe cardiopulmonary disease.
- •abnormal renal function tests.
- •allergy to local anesthetics.
研究组 & 干预措施
study group :infiltration with 0.25% bupivacaine post-op
At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin
干预措施: Marcaine Injectable Product (Drug)
结局指标
主要结局
visual analogue scale (VAS )
时间窗: 1, 4, 8, 12, 24, and 48 hours
Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours
Dynamic Visual Analogue Scale (DVAS)
时间窗: 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours
Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours
次要结局
- The time for the first opioid demand(48 hours)
- the number of opioid demands(48 hours)
- total opioid consumption(48 hours)
研究者
Saddam Al Demour
Assistant Professor
University of Jordan