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临床试验/NCT03408340
NCT03408340终止4 期

Paravertebral Nerve Blocks in Neonates and Infants Undergoing Repair of Aortic Coarctation, A Pilot Study

Emory University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年7月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
16
试验地点
1
主要终点
Morphine Equivalents

研究概览

简要总结

This study is a prospective, randomized, non-blinded clinical trial examining the use of paravertebral peripheral nerve block in the neonatal and infant populations. The primary aim of this study is to determine the feasibility of studying whether a single-shot paravertebral nerve block is effective in providing intraoperative and postoperative pain control in infants undergoing a thoracotomy for coarctation of the aorta. This will be determined by comparing consumption of narcotics, expressed as morphine equivalents, in the standard of care and intervention groups.

详细描述

Pain and pain control remain a major concern in the neonatal and infant populations and pain is often undertreated in order to achieve other goals of medical management. Pain control with narcotic medications create an additional concern as withdrawal from narcotics can become an issue in neonates and infants requiring long-term administration of pain medications. A regional block is an alternative way to control pain by directly blocking the nerves through injecting medication near their course.

A paravertebral block (PVB) is a regional block of some of the spinal nerves. The paravertebral space is a wedge shaped space that is located next to the bony structures of the spine. This space is where the nerves of the spine branch out to the body which makes this space an ideal location to deliver numbing drugs for pain. An ultrasound probe is used to ensure that the medicine goes into the paravertebral space. This study will compare the use of the standard of care intravenous pain medication to the use of a PVB.

Using a PVB to control pain may also lead to better blood flow to the spinal cord. A Near Infrared Spectroscopy (NIRS) monitor will be used to monitor the oxygen levels in the spine tissues. This study aims to determine if using a paravertebral block in addition to standard of care anesthesia results in better pain control and blood flow to the spine.

A total of 30 neonates and infants, defined as children less than 12 months of age, will be enrolled in this study. The subjects will be scheduled for elective or semi-elective cardiac surgery at Children's Healthcare of Atlanta. At the time of surgery they must be greater than or equal to 2.5 kg and undergoing aortic coarctation repair via left thoracotomy.

Post-operative pain control in either the control or experimental (paravertebral nerve block) group will be accomplished with intravenous, rectal, and oral analgesics. Patients will receive scheduled rectal acetaminophen while intubated and oral acetaminophen once they have progressed to oral intake of formula. Intravenous fentanyl will be used for breakthrough pain while intubated and until oral intake is tolerated. Once oral intake is resumed, the patient will be provided with oral oxycodone as needed for pain per usual Cardiac Intensive Care Unit (CICU) care. If the patient is not yet ready for extubation and requires additional sedation, intravenous doses of midazolam may be required.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Neonate or Infant (<12 months age) at the time of surgery
  • Weigh of 2.5 kilograms or more at the time of surgery
  • Undergoing aortic coarctation repair via left thoracotomy
  • Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

排除标准

  • Intubated prior to surgery (patients who have been intubated and subsequently extubated may be included)
  • Ongoing septicemia or localized skin infection on the back
  • Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
  • Known coagulation defect
  • Allergy to local anesthetics

研究组 & 干预措施

Paravertebral Nerve Block

Experimental

Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.

干预措施: Paravertebral Nerve Block (Procedure)

Standard of Care Anesthesia

Active Comparator

Participants in the control arm will undergo an anesthetic consistent with the standard of care.

干预措施: Standard of Care Anesthesia (Drug)

结局指标

主要结局

Morphine Equivalents

时间窗: 48 hours after surgery

To measure total narcotic administration, all narcotics used in the 48-hour postoperative period will be tabulated and converted to morphine equivalents. The total morphine equivalents will be compared between study arms.

次要结局

  • Near Infrared Spectroscopy (NIRS) Values(At the end of surgery up to 5 hours)
  • Postoperative Ventilation Time(Up to 2 days (typical duration of time in ICU post-surgery))
  • Time to First Feeding(Up to 7 days (typical duration of time until hospital discharge))
  • Change in Plasma Epinephrine Levels(Baseline, 24 hours after surgery)

研究者

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

Justin B. Long

Associate Professor

Emory University

研究点 (1)

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