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Paravertebral Nerve Blocks in Neonates

NCT03408340 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-24

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

PROCEDURE

Paravertebral Nerve Block

Participants will be induced for anesthesia with propofol 3 milligram/kilogram (mg/kg) or ketamine 2mg/kg (if there is intravenous (IV) access) or sevoflurane with 1 microgram/kilogram (mcg/kg) of fentanyl and 1.2 mg/kg rocuronium once IV access is established. A NIRS pad will be used for cerebral oximetry as well as another NIRS pad for spinal cord oximetry. The patient will be intubated and then will be positioned laterally for the nerve block at approximately the left T3-4 level. A linear ultrasound probe with a sterile sheath will be used to provide imaging for the paravertebral nerve block. The injected solution will be 1 milliliter/kilogram (mL/kg) of 0.2% ropivacaine with 5 mcg/mL (1:200,000) epinephrine. Fentanyl may be used as needed for additional analgesia and anesthesia will be maintained with sevoflurane. The skin will not be infiltrated with additional local anesthetic at the conclusion of the case.

DRUG

Standard of Care Anesthesia

Participants in this arm will be induced for anesthesia with propofol 3mg/kg or ketamine 2mg/kg (if there is intravenous access) or sevoflurane with 1 mcg/kg of fentanyl and 1.2 mg/kg rocuronium once IV access is established. The patient will be intubated; intravenous and intra-arterial access will be obtained and the patient will be positioned for surgery. Fentanyl may be used as needed for additional analgesia and anesthesia will be maintained with sevoflurane. The skin will be infiltrated at the conclusion of surgery with less than 1 mL/kg of 0.25% bupivacaine with epinephrine 1:200,000.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Justin B Long, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-07-28
Completion
2020-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408340 on ClinicalTrials.gov