Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Pain scoring (CHEOPS)
研究概览
简要总结
Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.
The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.
-But these methods are not widely used in pediatrics upon our knowledge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing laparoscopic surgeries
- •Pediatric weighing 4 kg or more
- •Patients with free medical history
排除标准
- •Parents refusal
- •Known allergy to levobupivacaine
- •Acute preoperative pain other than biliary colic
- •chronic pain treatment or antiepileptic therapy
- •Severe hepatic or renal impairment
- •Cognitive impairment or communication problems.
研究组 & 干预措施
Chirocaine group (levobupivacaine )
干预措施: Levobupivacaine 0.5% (Drug)
Control group
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative Pain scoring (CHEOPS)
时间窗: up to six hours
pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.
次要结局
- changes in Haemodynamics including ( Non Invasive Blood Pressure)(during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6)
- changes in Haemodynamics including ( Heart Rate)(during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6)
研究者
Sherif Mohamed Abd el moneim Soaida, MD
Lecturer
Cairo University