Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time of the first postoperative analgesic request
研究概览
简要总结
To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.
详细描述
The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients, parents and data analysts will be blinded to group assignments.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age starting from 5 to 12 years.
- •Genders eligible for study: both sexes.
- •American Society Of Anesthesia (ASA) I-III.
- •Scheduled to undergo laparoscopy.
排除标准
- •Refusal of regional block or patients requiring emergency procedures.
- •Known Local Anesthetics drug sensitivity
- •Bleeding disorders with International Normalised Ratio (INR) > 1.5 and/or platelets < 100
- •Skin lesions or wounds at site of proposed needle insertion.
- •Evidence of peritonitis or septicemia.
- •Hepatic disease or enlargement.
结局指标
主要结局
Time of the first postoperative analgesic request
时间窗: starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours
(duration of the block, time spent post-operative before rescue opioid is needed at pain score of 6 or higher, up to 12 hours post operative.
次要结局
- total opioid consumption over the first 12 hours.(through out the first 12 hours post operative.)
- The incidence of post block adverse effects(starting after the block is given up to the first 12 hours post operative)
- Pain score up to 12 hours after surgery.(through out the first 12 hours post operative.)
- Block failure(through out the first hour post operative.)
- Block performance time(starting from probe contact with skin till 30 minutes.)
- Ease of performance of each technique(through out the block performance time)
研究者
Eslam Ragab ElSayed Mohamed Heggy
Principal Investigator
Kasr El Aini Hospital