Paravertebral Nerve Blocks in Neonates

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Anesthetics; Fentanyl; Ketamine; Propofol; Rocuronium; Sevoflurane

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