Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Patients Who Receive Bilateral, Pre-incision ESPB
研究概览
简要总结
Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population.
The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-19 years old
- •Patients undergoing multilevel posterior spinal instrumentation and fusion
- •Undergoing surgery for correction of adolescent idiopathic scoliosis
- •Patients under the care of participating surgeons
- •English Speaking
排除标准
- •Patients younger than 10 years old or older than 19 years old
- •Neuromuscular scoliosis
- •Patient under the care of non-participating surgeon performing the procedure
- •History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks)
- •Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin)
- •Allergy, intolerance, or contraindication to any protocol component/study medication/technique
- •Patient or parent refusal
- •Non-english speaking
结局指标
主要结局
Number of Patients Who Receive Bilateral, Pre-incision ESPB
时间窗: through study completion, an average of 1 year
number who receive the intervention and complete all assessments
次要结局
- Rate of Recruitment(through study completion, an average of 1 year)
- Attrition(through study completion, an average of 1 year)
- Blinding Assessment(24 hours after surgery)
- Number of Participants Unable to Receive ESPB Block.(Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery)
- Incidence of Intra- and Postoperative Complications Attributed to ESPB(During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery)
- Pain Scores at Rest and Movement(PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days))
- Total Opioid Consumption(0-24 hours after surgery (OME within 24 hrs))
- Time to First Opioid Use(Up to 24 hours after surgery)
- Patient/Parent Satisfaction With Pain Management(At hospital discharge (an average of 4 days))
- Opioid Related Side Effects(24 hours after surgery)