Paravertebral Nerve Blocks in Neonates

March 20, 2025 updated by: Justin B. Long, Emory University

Paravertebral Nerve Blocks in Neonates and Infants Undergoing Repair of Aortic Coarctation, A Pilot 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain and pain control remain a major concern in the neonatal and infant populations and pain is often undertreated in order to achieve other goals of medical management. Pain control with narcotic medications create an additional concern as withdrawal from narcotics can become an issue in neonates and infants requiring long-term administration of pain medications. A regional block is an alternative way to control pain by directly blocking the nerves through injecting medication near their course.

A paravertebral block (PVB) is a regional block of some of the spinal nerves. The paravertebral space is a wedge shaped space that is located next to the bony structures of the spine. This space is where the nerves of the spine branch out to the body which makes this space an ideal location to deliver numbing drugs for pain. An ultrasound probe is used to ensure that the medicine goes into the paravertebral space. This study will compare the use of the standard of care intravenous pain medication to the use of a PVB.

Using a PVB to control pain may also lead to better blood flow to the spinal cord. A Near Infrared Spectroscopy (NIRS) monitor will be used to monitor the oxygen levels in the spine tissues. This study aims to determine if using a paravertebral block in addition to standard of care anesthesia results in better pain control and blood flow to the spine.

A total of 30 neonates and infants, defined as children less than 12 months of age, will be enrolled in this study. The subjects will be scheduled for elective or semi-elective cardiac surgery at Children's Healthcare of Atlanta. At the time of surgery they must be greater than or equal to 2.5 kg and undergoing aortic coarctation repair via left thoracotomy.

Post-operative pain control in either the control or experimental (paravertebral nerve block) group will be accomplished with intravenous, rectal, and oral analgesics. Patients will receive scheduled rectal acetaminophen while intubated and oral acetaminophen once they have progressed to oral intake of formula. Intravenous fentanyl will be used for breakthrough pain while intubated and until oral intake is tolerated. Once oral intake is resumed, the patient will be provided with oral oxycodone as needed for pain per usual Cardiac Intensive Care Unit (CICU) care. If the patient is not yet ready for extubation and requires additional sedation, intravenous doses of midazolam may be required.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paravertebral Nerve Block
Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.
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.
Other Names:
  • Naropin
  • Ketalar
  • Diprivan
  • Zemuron
  • Ultane
  • Duragesic
  • adrenalin
Active Comparator: Standard of Care Anesthesia
Participants in the control arm will undergo an anesthetic consistent with the standard of care.
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.
Other Names:
  • Marcaine
  • Ketalar
  • Diprivan
  • Zemuron
  • Ultane
  • Duragesic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine Equivalents
Time Frame: 48 hours after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Near Infrared Spectroscopy (NIRS) Values
Time Frame: At the end of surgery up to 5 hours
Spinal cord perfusion will be assessed by continuous measurement of spinal cord near-infrared spectroscopy (NIRS) values during the repair of aortic coarctation, including the aortic cross-clamp period. (NIRS), a non-invasive light probe that measures regional oxygen saturation (rSO2). Decreased spinal cord perfusion (compromised blood flow) is associated with severe morbidities.
At the end of surgery up to 5 hours
Postoperative Ventilation Time
Time Frame: Up to 2 days (typical duration of time in ICU post-surgery)
Postoperative ventilation time will be measured as the time, in minutes, until extubation. This time will be compared between study arms.
Up to 2 days (typical duration of time in ICU post-surgery)
Time to First Feeding
Time Frame: Up to 7 days (typical duration of time until hospital discharge)
Return to feeding after surgery will be measured as hours until the first postoperative feeding.
Up to 7 days (typical duration of time until hospital discharge)
Change in Plasma Epinephrine Levels
Time Frame: Baseline, 24 hours after surgery
Stress response to surgery will be evaluated by measuring plasma epinephrine levels at baseline (before incision), postoperatively (just before transfer to the Intensive Care Unit), and 24 hours postoperatively.
Baseline, 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justin B Long, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00093442

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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