Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Length of Stay (LOS)
研究概览
简要总结
Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Diagnosed with Idiopathic scoliosis
- •Undergoing single-stage posterior spinal instrumentation and fusion
排除标准
- •Thorascopic tethering procedure
- •Two-stage procedure
- •Abnormal developmental profile
- •Congenital/neuromuscular scoliosis
- •Requiring PICU admission
- •Known allergy to lidocaine
- •Known cardiac, renal or liver disease or dysfunction
- •Pre-existing pain complaints, i.e. on regular analgesic medications
- •Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
- •Requiring non-standard post-op pain management
- •Any history of seizures
- •Unplanned staged procedure
- •Weight < 5th centile or > 85th centile for age
- •Porphyria
结局指标
主要结局
Length of Stay (LOS)
时间窗: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Maximum lidocaine plasma concentration [Cmax]
时间窗: Through hospital stay, an average of 5 days
Measure daily serial plasma lidocaine levels from ESPB catheters
Patient-Reported Pain Scores
时间窗: Through hospital stay, an average of 5 days
Patients will be asked on a daily basis by the research staff to report pain scores on a scale of 1-10 (1 signifying no pain to 10 signifying the worse pain).
Postoperative Opioid Consumption
时间窗: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Inpatient Postoperative Mobility
时间窗: Through hospital stay, an average of 5 days
Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.
次要结局
未报告次要终点
研究者
Chi-Ho Ban Tsui
Principal Investigator
Stanford University