Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Ropivacaine Concentrations
研究概览
简要总结
The primary aim of this study is to evaluate the pharmacokinetics of serum ropivacaine concentrations following erector spinae plane peripheral nerve blocks in the pediatric population.
Secondary outcomes will assess the efficacy of the block with perioperative morphine equivalent consumption and pain scores.
详细描述
This pilot study will enroll patients at Texas Children's Hospital, aged 6 months to <18 years scheduled to undergo a clinically indicated thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. A single shot erector spinae plane block is commonly offered for unilateral video-assisted thoracoscopic surgery (VATS) and unilateral chest tube insertions. Following parental consent and child assent to the block, participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg. This pilot study poses no additional risk to the patient and the thoracic surgical procedures outlined are those for which an erector spinae plane block would be offered. Furthermore, the block dosing of 0.3ml/kg volumes with ropivacaine 0.2% or 0.5% are not outside of the standard of care or accepted dosages for peripheral nerve blocks.
Venous sample serum ropivacaine levels will be collected prior to ESP block and at 30, 60, 90-minutes and 2, 4, 6 -hours from intravenous access in situ. A baseline alpha-1 acid glycoprotein (AGP) test will be collected and processed by TCH Pathology. Amide local anesthetics are predominantly protein bound to AGP. It is the unbound form that is active. While this study seeks to understand the pharmacokinetics of ropivacaine following a single shot erector spinae plane block, correlate of the AGP will simultaneously ascertain the free vs bound portion.
Samples will be analyzed for the total and free serum ropivacaine concentrations. Pain scores will be collected from nursing records starting from arrival in the Post-Anesthesia Care Unit every 4 hours (up to 12 hours after arrival in PACU). Pain will be measured using The Face, Legs, Activity, Cry, Consolability scale (FLACC), the Wong-Baker FACES Pain Rating Scale (FACES), and the Visual Analogue Scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months - < 18 years old;
- •Chest tubes or minimally invasive video assisted thoracic surgery;
- •Surgery scheduled between 7AM and 5PM
- •Weight greater than 4kg
排除标准
- •Renal dysfunction;
- •Liver dysfunction;
- •Hypoalbuminemia;
- •Allergy to local anesthetic;
- •Spinal hardware or instrumentation;
- •Scoliosis;
- •Obesity defined as a BMI >95% percentile
研究组 & 干预措施
Ropivacaine 0.2% at 0.3ml/kg
Ropivacaine 0.2% at 0.3ml/kg
干预措施: Ropivacaine (Drug)
Ropivacaine 0.5% at 0.3ml/kg
Ropivacaine 0.5% at 0.3ml/kg
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Ropivacaine Concentrations
时间窗: Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ
Pharmacokinetics(PK) of free and total serum ropivacaine concentrations following erector spinae plane peripheral nerve block administration. Blood samples were drawn at the indicated time points for each subject. Laboratory assays will be completed and resulted for all subject samples collected.
次要结局
- Morphine Equivalents(12 hours)
- Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating Scale(Every 4 hours (up to 12 hours after arrival in PACU))
- Post-anesthesia Care Unit Pain Scores Using FLACC Scale(Every 4 hours (up to 12 hours after arrival in PACU))
- Post-anesthesia Care Unit Pain Scores Using VAS(Every 4 hours (up to 12 hours after arrival in PACU))
研究者
Karla Elizabeth Wyatt
Assistant Professor
Baylor College of Medicine