The Effect of Erector Spinea Plane Block on the Postoperative Analgesia in Pediatric Hip Surgery: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total morphine consumption in the first postoperative day
研究概览
简要总结
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome.
The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.
详细描述
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries.
Primary outcome: Total morphine consumption in the first postoperative day. Secondary outcome: The time to first request for rescue analgesia and postoperative pain score.
This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month that may be extended on pediatric patients scheduled for surgical treatment of hip disorder under general anesthesia.
A written informed consent will be obtained from the parents of all patients. Randomization will be performed by an independent data manager assigned the patients to groups based on a computer-generated randomization program introduced in closed opaque envelope.
Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at the level of second lumbar vertebra after induction of anesthesia and before the start of surgery without injection of local anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sham ESP block will be administrated in the control group Measurements will be obtained by anesthetist not participating in the study and blinded to its group
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study
排除标准
- •Parental refusal.
- •Preexisting spinal deformity or profound mental retardation.
- •Obese Children
- •Known or suspected allergy to local anesthetics.
- •Known or suspected coagulopathy
- •Major cardiac, renal, or hepatic disorders.
- •Children undergoing combined or bilateral surgeries.
结局指标
主要结局
Total morphine consumption in the first postoperative day
时间窗: The first 24 hours after surgery
Calculation of the total dose of morphine consumed in the first day after surgery
次要结局
- The time to first request for rescue analgesia(The first 24 hours after surgery)
- Postoperative pain score(every 2 hours in the first 8 hours then every 4 hours till 24 hours)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Assistant Professor of Anesthesia - Tanta Faculty of Medicine
Tanta University