PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- FLACC score
研究概览
简要总结
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.
详细描述
The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients will be randomly allocated to receive ultrasound-guided PENG block, ESP block, or only spinal anesthesia by computer software 1:1:1. A researcher who will not involve in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The patients and their anesthesia team, surgeon, operating room staff, and parents will be masked to the study group allocation. Group blinding unmasking will only occur once the statistical analysis is complete.
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients aged between 0-12 years who will undergo hip surgery
排除标准
- •a history of chronic pain use of gabapentin/pregabalin for > 3 months opioid use > 1 repeated opioid prescription in the last three months
- •morbid obesity (BMI > 99th percentile)
- •Infection at block application area
- •coagulopathy
研究组 & 干预措施
Control group
regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine
干预措施: Standard care (Other)
Pericapsular nerve group block (PENG) group
regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL
干预措施: Pericapsular nerve group block using 0.2% ropivacaine (Drug)
Erector Spinae Plane Block (ESPB) group
regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL
干预措施: Erector Spinae Plane Block using 0.2% ropivacaine (Drug)
结局指标
主要结局
FLACC score
时间窗: 48 hours after surgery
The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.
次要结局
- NLR(48 hours after surgery)
- total opioid consumption(48 hours after surgery)
- PLR(48 hours after surgery)