TerminatedPhase 4

Paravertebral Nerve Blocks in Neonates

Stopped: The study activities were suspended due to COVID-19, and the interim analysis did not yield positive results once resumed.

United States16 participantsStarted 2018-07-18

Plain-language 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 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.

Who can participate

Age range12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Morphine Equivalents

Timeframe: 48 hours after surgery

Trial details

NCT IDNCT03408340

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-28

Results submitted2025-03-05

View on ClinicalTrials.gov More Congenital Heart Disease trials