TerminatedPhase 4Other

Paravertebral Nerve Blocks in Neonates

Sponsored by Emory University

NCT ID
NCT03408340
Target Enrollment
16 participants
Start Date
2018-07-18
Est. Completion
2020-07-28

About This Study

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 Studied

Congenital Heart Disease

Interventions

  • Paravertebral Nerve Block
  • Standard of Care Anesthesia

Eligibility

Age:N/A - 12 Months
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (1)

Children's Healthcare of Atlanta
Atlanta, Georgia, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source