Congenital Heart DiseasePhase 4NCT03408340
Paravertebral Nerve Blocks in Neonates
A Phase 4 study testing Paravertebral Nerve Block in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Paravertebral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 28 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Paravertebral Nerve Block, Standard of Care Anesthesia
- Keywords
- Anesthesiology, Pediatric surgery, Anesthesia, Regional, Anesthesia, Cardiac Procedures, Nerve Block
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral Nerve BlockProcedure or surgery
Also called Diprivan, Ketalar, Ultane, Duragesic
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.
Standard of Care AnesthesiaDrug
Also called Diprivan, Ketalar, Ultane, Duragesic
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.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Nerve Block | Experimental | Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block. Receives: 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. Receives: Drug: Standard of Care Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after surgery
Secondary outcomes (4)
Near Infrared Spectroscopy (NIRS) Values
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.
Measured: At the end of surgery up to 5 hours
Postoperative Ventilation Time
Postoperative ventilation time will be measured as the time, in minutes, until extubation. This time will be compared between study arms.
Measured: Up to 2 days (typical duration of time in ICU post-surgery)
Time to First Feeding
Return to feeding after surgery will be measured as hours until the first postoperative feeding.
Measured: Up to 7 days (typical duration of time until hospital discharge)
Change in Plasma Epinephrine Levels
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.
Measured: Baseline, 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start18 Jul 2018
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Why it stopped: The study activities were suspended due to COVID-19, and the interim analysis did not yield positive results once resumed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin B. Long, Emory University
- Investigators
- Justin B Long, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408340
- Sponsor's protocol ID
- IRB00093442
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2018
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Nerve Blocks in Neonates and Infants Undergoing Repair of Aortic Coarctation, A Pilot Study
- ClinicalTrials.gov ID
- NCT03408340
- Acronym / sponsor ID
- IRB00093442
- Conditions
- Congenital Heart Disease
- Keywords
- Anesthesiology, Pediatric surgery, Anesthesia, Regional, Anesthesia, Cardiac Procedures, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study activities were suspended due to COVID-19, and the interim analysis did not yield positive results once resumed.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Nerve Block | Experimental | Procedure: Paravertebral Nerve BlockParticipants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block. |
| Standard of Care Anesthesia | Active comparator | Drug: Standard of Care AnesthesiaParticipants in the control arm will undergo an anesthetic consistent with the standard of care. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral Nerve BlockAlso: Diprivan, Ketalar, Ultane, DuragesicParticipants 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. | Procedure or surgery | Paravertebral Nerve Block |
| Standard of Care AnesthesiaAlso: Diprivan, Ketalar, Ultane, DuragesicParticipants 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. | Drug | Standard of Care Anesthesia |
Primary outcome
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.
4 secondary outcomes
Near Infrared Spectroscopy (NIRS) Values
Time frame: 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)
Time to First Feeding
Time frame: Up to 7 days (typical duration of time until hospital discharge)
Change in Plasma Epinephrine Levels
Time frame: Baseline, 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Congenital Heart Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin B Long, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paravertebral Nerve Block in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalents (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.