The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain After Laparoscopic Varicocelectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KBC Split
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain (as measured by Visual analogue scale)
研究概览
简要总结
Aim of this study is to examine the effects of subcutaneously applied local anesthetics at trocar site in combination with intraoperative intraperitoneal analgesia on duration and character of pain in pediatric patients undergoing laparoscopic varicocelectomy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients with varicocele who underwent laparoscopic varicocelectomy
- •pediatric patients whose parents or guardians gave informed consent
排除标准
- •patients who received open or microsurgical varicocelectomy
- •pediatric patients who underwent conversion to open procedure
- •pediatric patients with chronic, metabolic and endocrine diseases
- •pediatric patients with systemic infections
研究组 & 干预措施
Lidocaine group
A total amount of 6 mL of 2% lidocaine was injected at the three trocar insertion sites (2 mL at each insertion site) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.
干预措施: 2% Lidocaine (Drug)
Levobupivacaine
Total amount of 6 mL of 0.5% levobupivacaine was injected at the three trocar insertion sites (2 mL at each) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.
干预措施: 0.5% levobupivacaine (Drug)
结局指标
主要结局
Pain (as measured by Visual analogue scale)
时间窗: 6 hours after surgery
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
次要结局
- Pain (as measured by Visual analogue scale)(24 hours after surgery)
研究者
Goran Tintor
Medical doctor, surgery resident
KBC Split