Paravertebral Nerve Blocks in Neonates

Phase 4

Terminated

• Conditions: Congenital Heart Disease
• Interventions: Drug: Standard of Care Anesthesia; Procedure: Paravertebral Nerve Block

• Registration Number: NCT03408340
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-07-18
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Anesthesia	Standard of Care Anesthesia	Participants in the control arm will undergo an anesthetic consistent with the standard of care.
Paravertebral Nerve Block	Paravertebral Nerve Block	Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.

Primary Outcome Measures

Name	Time	Method
Morphine equivalents	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.

Secondary Outcome Measures

Name	Time	Method
Near infrared spectroscopy (NIRS) values	At the end of surgery	Spinal cord perfusion will be assessed by continuous measurement of spinal cord near infrared spectroscopy (NIRS) values during repair of aortic coarctation, including the aortic cross clamp period. (NIRS), a non-invasive light probe that measures regional oxygen saturation. Decreased spinal cord perfusion (compromised blood flow) is associated with severe morbidities.
Postoperative ventilation time	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.
Time to first feeding	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.
Change in plasma epinephrine levels	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.

Trial Locations

Locations (1)

Children's Healtcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States