Continuous Erector Spinae Plane Local Anesthetic Infusion for Postoperative Analgesia in Pediatric Patients Undergoing Nephrectomy: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- total amount of opioid consumption in milligram
研究概览
简要总结
The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy
详细描述
- Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30).
- All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status ASA II.
- •Patients (age 2-7yrs) scheduled for open nephrectomy for malignant kidney tumors
排除标准
- •History of psychological disorders.
- •Known sensitivity or contraindication to local anesthetics.
- •Localized infection at the site of block.
- •patients with coagulopathy or an (INR ≥ 2)
研究组 & 干预措施
Erector spinae group
patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.
干预措施: Bupivacaine Hydrochloride (Drug)
Opioid GROUP
Patient in group T will intravenously administrate dose of 1 mg/kg/8hr tramal ( opioid) to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic.
干预措施: Tramadol hydrochloride (Drug)
结局指标
主要结局
total amount of opioid consumption in milligram
时间窗: 48 hours
total amount of opioid consumption in the frist 48hours postoperative
次要结局
未报告次要终点
研究者
Fatma Adel El sherif,MD
Associated professor of anesthesia,ICU and pain management
Assiut University