Paravertebral Nerve Blocks in Neonates
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | July 18, 2018 |
| End Date: | December 2019 |
| Contact: | Justin B Long, MD |
| Email: | justin.bradley.long@emory.edu |
| Phone: | 404-785-6670 |
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.
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.
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.
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.
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
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