跳至主要内容
临床试验/NCT02860091
NCT02860091终止不适用

Blood Ropivacaine Concentrations Following Unilateral Chest Wall Nerve Block and Continuous Infusion in Infants and Toddlers Undergoing Thoracotomies

Boston Children's Hospital1 个研究点 分布在 1 个国家实际入组 26 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1
主要终点
Blood ropivacaine concentration

研究概览

简要总结

The main objective of this proposed investigation is to evaluate blood ropivacaine concentrations in infants and toddlers following the initiation of, and over the course of, continuous paravertebral nerve blockade using ropivacaine infusion for postoperative pain control following esophageal atresia repair procedures that include posterior tracheopexy.

Continuous unilateral chest wall nerve blockade (CUCWNB) using ropivacaine is the current standard of practice for this surgical population at the investigators' institution and, as such, this study does not aim to alter the current standard clinical care received by participants but rather evaluate the blood concentrations of ropivacaine as it is routinely used.

详细描述

Post-surgical pain management is often suboptimal in pediatric patients, especially in those with complex past medical and past surgical histories. Physicians generally, and physicians at Boston Children's Hospital (BCH), in particular, are employing regional anesthetic techniques as either primary or adjunct measures for perioperative pain control. One of the benefits of regional anesthesia is the avoidance, or at least limitation of, opioid and benzodiazepine exposure.

CUCWNB is a regional anesthesia technique that uses an indwelling catheter, placed under ultrasound guidance, which terminates in the paravertebral space for a paravertebral nerve block or at the base of the erector spinae muscle complex immediately lateral to the paravertebral space for an erector spinae nerve block. Introduction of local anesthetic through this catheter produces ipsilateral somatic and sympathetic nerve blockade in multiple contiguous dermatomes. The technique provides effective analgesia for unilateral thoracic and abdominal surgical procedures.

CUCWNB using ropivacaine is used regularly at this institution for patients of all ages as a part of various multimodal intra- and post-operative pain management strategies. The success of CUCWNB implementation for infants and toddlers undergoing thoracotomies has been so marked that this technique has become essentially a de facto standard of care for this population at BCH.

Unfortunately, even as of today, studies demonstrating the pharmacokinetic profile of ropivacaine CUCWNB in infants and toddlers are not available. A few studies have examined plasma levels of ropivacaine after single injection paravertebral nerve blocks in adult patients. For example, a single bolus injection of 2mg/kg was well tolerated, not exceeding peak plasma concentrations of 2.5 µg/ml, well below the concentration considered a threshold for ropivacaine local anesthetic systemic toxicity (LAST). However, it is unclear how applicable this data is to our complex pediatric surgical patients at BCH.

In order to more fully understand plasma ropivacaine concentrations during CUCWNB, and particularly how these concentrations relate to known thresholds for ropivacaine-induced systemic local anesthetic toxicity, the investigators plan to measure plasma concentrations of ropivacaine at various time points following initiation of CUCWNB in infant and toddler patients having just undergone esophageal atresia repair with posterior tracheopexy.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
— 至 4 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • Infants and toddlers (0-4) years
  • Undergoing a procedure that requires a thoracotomy for esophageal atresia repair and related procedures
  • Receiving ropivacaine via continuous paravertebral nerve block catheter or erector spinae catheter

排除标准

  • Hepatic dysfunction
  • Local anesthetic allergy

研究组 & 干预措施

Ropivacaine infusion

Patients receiving continuous ropivacaine infusion for approximately 7 days via paravertebral nerve block or erector spinae catheter managed according to existing institutional protocols.

干预措施: Ropivacaine infusion (Drug)

结局指标

主要结局

Blood ropivacaine concentration

时间窗: 7 days

Plasma ropivacaine concentration

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Roland Brusseau

Instructor

Boston Children's Hospital

研究点 (1)

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标识符

NCT 编号
NCT02860091
其他研究编号
IRB-P00022295

日期

首次提交
(10年前)
首次发布
(10年前)
主要完成日期
(4个月前)
研究完成日期
(4个月前)
最近核实
(5个月前)
最近更新
(4个月前)

监管与共享

FDA 监管药物
是
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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