Clinical trial NCT03408340: Paravertebral Nerve Blocks in Neonates
Official title: Paravertebral Nerve Blocks in Neonates and Infants Undergoing Repair of Aortic Coarctation, A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Congenital Heart Disease
Keywords: Anesthesiology
Pediatric surgery
Anesthesia, Regional
Anesthesia, Cardiac Procedures
Nerve Block
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 16
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine Equivalents
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Near Infrared Spectroscopy (NIRS) Values
timeFrame: At the end of surgery up to 5 hours
measure: Postoperative Ventilation Time
timeFrame: Up to 2 days (typical duration of time in ICU post-surgery)
measure: Time to First Feeding
timeFrame: Up to 7 days (typical duration of time until hospital discharge)
measure: Change in Plasma Epinephrine Levels
timeFrame: Baseline, 24 hours after surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Justin B Long, MD
role: PRINCIPAL_INVESTIGATOR
References: