Status:

TERMINATED

Paravertebral Nerve Blocks in Neonates

Lead Sponsor:

Emory University

Conditions:

Congenital Heart Disease

Eligibility:

All Genders

Up to 12 years

Phase:

PHASE4

Brief Summary

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 t...

Detailed Description

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 med...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 18 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 28 2020

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT03408340

Start Date

July 18 2018

End Date

July 28 2020

Last Update

March 24 2025

Active Locations (1)

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342