IV Lidocaine in Pediatric AIS

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 25, 2019

Keywords

ClinConnect Summary

This study is a Phase IV clinical trial testing whether giving an intravenous lidocaine infusion around the time of surgery can reduce the amount of opioid pain medicine needed after spinal fusion surgery for adolescent idiopathic scoliosis (AIS). It’s a randomized, triple-blind study, meaning participants, their care team, and the researchers assessing outcomes don’t know who receives lidocaine or placebo. There are two groups: one gets IV lidocaine during and after surgery, the other gets a saline placebo, in addition to standard post‑operative care. The main goal is to see if lidocaine lowers opioid use in the hospital and up to 6 weeks after surgery, and to learn about recovery using patient-reported measures of pain and mobility, plus some immune-related outcomes.

Eligible participants are youths aged 12–18 with AIS who are planned for posterior spinal fusion and can provide informed consent (with a parent or guardian) and complete study surveys. Exclusions include age outside 12–18, inability to consent, current infection or cancer, participation in another trial, certain heart rhythm or seizure conditions, allergy to lidocaine or related drugs, planned anterior spine surgery, limited English proficiency, or being a ward of the state. The study is being conducted at Barnes Jewish Hospital/St. Louis Children’s Hospital with Washington University in St. Louis, and results are not yet available. Enrollment is by invitation, and the study team hopes to enroll about 70 participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion.
• • 2. Ages between 12 and 18 years of age.
• • 3. Parent/Guardian capable of providing informed consent for study participation
• Exclusion Criteria:
• • 1. Age \< 12 or \> 18 years old.
• • 2. Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.
• • 3. Diagnosis of sepsis or infection
• • 4. Diagnosis of primary or metastatic malignancy.
• • 5. Participation in another clinical trial.
• • 6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.
• • 7. Past or current seizure disorders.
• • 8. Allergy to bupivacaine.
• • 9. Planned anterior approaches for treatment of scoliosis deformity.
• • 10. Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)
• • 11. Ward of the State children