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临床试验/NCT04258436
NCT04258436终止不适用

Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery

Indiana University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Measurement of Postoperative Narcotic Exposure

研究概览

简要总结

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.

详细描述

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management.

Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution.

Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block.

Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

盲法说明

Pediatric Cardiovascular ICU personnel will be blinded to the randomization assignment

入排标准

年龄范围
38 Weeks 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 12 months of age or less
  • Infants undergoing cardiac surgery through a thoracotomy incision
  • Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital

排除标准

  • Infants requiring sternotomy or emergency surgery
  • Allergy to local anesthetics
  • Neonates less that 37 weeks gestation
  • Infants intubated prior to surgery
  • Infection at the site of the Serratus Anterior Plane Block
  • Bleeding diathesis with increased risk of hematoma at the block site
  • Allergy to morphine
  • Active pulmonary infection

结局指标

主要结局

Measurement of Postoperative Narcotic Exposure

时间窗: From start of anesthesia to 24 hours postoperatively

Total morphine equivalents in first 24 hours

次要结局

  • Duration of Mechanical Ventilation(From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days)
  • Adverse events(From block placement until 72 hours post operatively)
  • Duration of Supplemental oxygen exposure(From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days)
  • Length of Cardiovascular ICU stay(From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days)
  • Postoperative Pain Scores(From arrival to ICU to 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania K. Abbasi

Associate Professor of Clinical Anesthesia

Indiana University

研究点 (2)

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