Paravertebral Nerve Blocks in Neonates

NCT03408340 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00093442
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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

Keywords

Anesthesiology; Pediatric surgery; Anesthesia, Regional; Anesthesia, Cardiac Procedures; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalents

  To measure total narcotic administration, all narcotics used in the 48-hour postoperative period will be tabulated and converted to morphine equivalents. The total morphine equivalents will be compared between study arms.

  48 hours after surgery

Secondary Outcomes (4)

• Near Infrared Spectroscopy (NIRS) Values

  At the end of surgery up to 5 hours

• Postoperative Ventilation Time

  Up to 2 days (typical duration of time in ICU post-surgery)

• Time to First Feeding

  Up to 7 days (typical duration of time until hospital discharge)

• Change in Plasma Epinephrine Levels

  Baseline, 24 hours after surgery

Study Arms (2)

Paravertebral Nerve Block

EXPERIMENTAL

Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.

Procedure: Paravertebral Nerve Block

Standard of Care Anesthesia

ACTIVE COMPARATOR

Participants in the control arm will undergo an anesthetic consistent with the standard of care.

Drug: Standard of Care Anesthesia

Interventions

Paravertebral Nerve Block PROCEDURE

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.

Also known as: Diprivan, Ketalar, Ultane, Duragesic, Zemuron, Naropin, adrenalin

Paravertebral Nerve Block

Standard of Care Anesthesia DRUG

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.

Also known as: Diprivan, Ketalar, Ultane, Duragesic, Zemuron, Marcaine

Standard of Care Anesthesia

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Propofol; Ketamine; Sevoflurane; Fentanyl; Rocuronium; Ropivacaine; Epinephrine; Bupivacaine

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols

Results Point of Contact

• Title: Justin B. Long, MD, Associate Professor
• Organization: Emory University

justin.bradley.long@emory.edu

404-785-6670

Study Officials

• Justin B Long, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in the study will be randomized to the control arm or experimental arm using computer-generated random assignment, which will be prepared at the start of the study and the assignments held in sealed envelopes. Once the participant is enrolled in the study and consent has been obtained the investigator will open the next consecutive sealed envelope which contains the patient's group assignment (experimental or control).

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: July 18, 2018
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Locations

US (1)