Paravertebral Nerve Blocks in Neonates and Infants Undergoing Repair of Aortic Coarctation, A Pilot Study
Overview
- Phase
- Phase 4
- Intervention
- Paravertebral Nerve Block
- Conditions
- Congenital Heart Disease
- Sponsor
- Emory University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Morphine Equivalents
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Justin B. Long
Associate Professor
Emory University
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
Arms & Interventions
Paravertebral Nerve Block
Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.
Intervention: Paravertebral Nerve Block
Standard of Care Anesthesia
Participants in the control arm will undergo an anesthetic consistent with the standard of care.
Intervention: Standard of Care Anesthesia
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Near Infrared Spectroscopy (NIRS) Values(At the end of surgery up to 5 hours)
- Postoperative Ventilation Time(Up to 2 days (typical duration of time in ICU post-surgery))
- Time to First Feeding(Up to 7 days (typical duration of time until hospital discharge))
- Change in Plasma Epinephrine Levels(Baseline, 24 hours after surgery)