Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Numerical Rating Scale
研究概览
简要总结
The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.
详细描述
This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
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 ESP block with 0,2% ropivacaine or ESP block with the sham block by computer software 1:1. A researcher who will not be involved 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 surgeon, patients, and anesthesia team will be masked to the study group. Group blinding unmasking will only occur once the statistical analysis is complete.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 10-18 years old
- •pediatric patients who will undergo the surgical correction of idiopathic scoliosis
排除标准
- •a history of chronic pain (use of gabapentin/pregabalin for > 3 months or opioid use > 1 repeated opioid prescription in the last three months)
- •morbid obesity (BMI > 99th percentile)
- •previous surgery
- •back abnormalities
- •infection at block application area
- •coagulopathy
研究组 & 干预措施
Sham group
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline
干预措施: Sham block (Drug)
ESPB group
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)
干预措施: ESPB (Drug)
结局指标
主要结局
Pain Numerical Rating Scale
时间窗: 48 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
次要结局
- platelet/lymphocyte ratio(12 hours and 24 hours after surgery)
- Nausea or Vomiting(during first 24 hours after surgery)
- total opioid consumption(Day 7 after surgery)
- neutrophil/lymphocyte ratio(12 hours and 24 hours after surgery)
- Motor Evoked Potential amplitude(up to 24 weeks following the correction of scoliosis)