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Paravertebral Nerve Blocks in Neonates
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.
Conditions:
🦠 Congenital Heart Disease
🗓️ Study Start (Actual) 18 July 2018
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: N/A to 12 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 January 2018
  • First Submitted that Met QC Criteria 17 January 2018
  • First Posted 24 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 January 2024
  • Last Update Posted 22 January 2024
  • Last Verified January 2024
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